Pfizer

Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.  

fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days after taking shot started to itch real bad and have hive like bumps. Currently still have itching bumps 4 days after shot

By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt achy and a little unsteady for the rest of the day but was fully recovered by 12/31

On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.

I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getting in my pajamas for the night and my husband noticed a weird rash on my body. It did not itch or hurt. I took a shower and a Tylenol and went to bed. I woke up at 5am the next morning and it was completely gone.

I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Systemic pruritis (itching) all over body; COVID test type: Nasal Swab and Rapid Antigen and were both positive; COVID test type: Nasal Swab and Rapid Antigen and were both positive; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscular on 17Dec2020 16:30 at single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and spironolactone. The patient previously took cefprozil (CEFZIL) and tapazole and both experienced allergies. The patient experienced systemic pruritis (itching) all over body on 22Dec2020 10:00. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has been tested for COVID-19. On 22Dec2020, the patient took COVID test type: Nasal Swab and Rapid Antigen and were both positive. No treatment received for the event "Systemic pruritis (itching) all over body". The outcome of the event "Systemic pruritis (itching) all over body" was not recovered. The outcome of the other events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this codition

-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs

Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration

Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.

12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.

Initial reaction (within 5 min) was minor chest tightening and at the 15 min mark I started to get hives, I let the nurses know of my reaction and they provided me with Benadryl, I then stayed for about an hour after. It has now been about a week, hives still present and starting to present as a rash.

on 7th day post vaccination, I had left upper arm swelling, rash, and pain where there had previously been none. Freckles on that upper arm scabbed over and peeled. This event lasted less than 2 hours. No medications taken, no medical care received. No further reaction since then.

Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain

Hives, started 24 hours after vaccine administration, present for about 1 week after vaccine dose, improved with antihistamine therapy. no lip/tongue swelling, shortness of breath, vomiting, syncope, hypotension

Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet and knee area. Patient got CBC and went to PCP. CBC was normal except platelets low-normal 150,000. No itching, swelling, etc. This occurred about 9 days after vaccination. Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine. No other symptoms reported besides sore arm for 2 days.

rash on body; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 04Jan2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to sulfa drug. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cipro [ciprofloxacin] and experienced allergy to cipro. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's husband noticed a rash on the patient's body when the patient was getting into pajamas for bed. She took a shower and paracetamol (TYLENOL) and went to bed. She woke up in the morning and rash was gone. The mother reported she became pregnant while taking bnt162b2. Last menstrual period date was 13Aug2020. The mother was 20 weeks pregnant at the onset of the event. The mother was due to deliver on 20May2021. Outcome of the rash was recovered. The events were considered non-serious by the reporter.

Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my throat started to hurt, and my chest started to hurt. I was a shot of EpiPen and benadryl before I was wheeled down to the ED and was given dexAMETHasone at 1:02pm and ibuprofen at 2:36pm cause my head started to hurt more . Arm is till hurting at the injection site

Right side of face started to swell with blotching. It then went away . Injection site is raised , swelling and itching along with bruising . Hives began again on my arms and injection site .

About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.

Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache

Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.

1.5 hrs after injection, patient noted redness, mild induration, warmth, tenderness; defined 6cm x 4cm affected area. No change in 3 days since injection; she presented to Health for assessment; site is defined, mild erythema, mild induration, tender. Recommended to apply cold pack, take ibuprofen as anti inflammatory, consult PCP and monitor, and return in 2 days 1/13/21 for update. Advised that PCP may possibly want to prescribe antibiotics if no improvement/resolution (possible cellulitis? does not appear as such to date)..

Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.

Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.

I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days. I slept a lot during the day and day after the injection . I did not get care from a hospital or doctor.

Heat and redness around injection site - occurred one day after injection and continues to be present

chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue

?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER

Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneous report from a contactable physician (patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (right arm), on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left arm), on 17Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021 at 21:00, the patient experienced low-grade temperature, myalgias, fatigue, neck pain, and injection site tenderness. The patient did not receive treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.

Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER

Started to feel itchy on right neck area approximately 5:25 5 minutes after receiving . Denies problems with breathing. No respiratory distress. Lungs ctabl, no stridor, no jvd. RR 12 unlabored even. CV Blood pressure 143/93 97 99% on RA after deep breaths BP 125/88 96b 99% O2 sat. Consulted with Medical Director called 911 for evaluation. Paramedics called and evaluated employee. They recommended on site observation and Benadryl. One 3-4 mm raised blanched wheal at right neck observed, "itchy" scratched x1 when itched. "Tried to not scratch" Denies any respiratory difficulty. Benadryl 25 mg given 6:21 PM, 6:52 employee doing well 98 % 85 heart rate 132/88 16 referral provided for if needed follow up care.

Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.

Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching

I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.

Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolved by am

Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.

2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.

I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.

Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.

Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.

Redness, tender and warm to touch at injection site, redness streaking down to inner side of right arm. Noticed redness and tenderness on day 2. Day 3 has slightly more redness surrounding injection site, 2 inch in diameter circular redness, and increased redness down arm. On day 3, the red streak is approximately 1 inch in width and 3 inches in length.

11:01 blotchy rash on L neck w/ pulsing sensation L neck. Anxiety, sense of impending doom. BP 167/98. Cap refill slow (recorded at 45 seconds). 11:05 25mg benadryl PO 11:09 mild chest pressure without SOB, no throat tightening or difficulty swallowing. 11:25 new R neck itching/rash and chest rash 11:30 another 25mg benadryl PO 12:00 increased rash across torso and back, BP 173/80 Presented to urgent care by 1:00PM, BP 157/96, increasing chest pressure, rash improving. EKG 12-lead completed (NSR w/ sinus arrhythmia). Instructed to take PO Benadryl 50mg every 4hrs.

I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began. During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol. On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.

8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.

Burning when it went in, tingling left arm down to hand, left left foot. Feels like it's getting worse. Advised to see PCP.

I started to notice some itching on my arms and chest and behind my ear so I went to the bathroom to check it out and I noticed the right side of my face was getting red and blotchy looking. I went to talk to the doctor and while I was conversing with her my tongue started to get tingly and started to swell. I took 50mg of benedryl and kept an eye on my symptoms and the tongue swelling started going down but the rash is still there.

After the first shot of Pfizer, I started to have cold sore ( never have cold sore before). I started to take cold sore shield pills one a day and using abreva to treat cold sore. While I am still treating cold sore, I received 2 nd dose of Covid. After exact 1 week of 2nd shot, I had an allergy reaction. I was driving to work and had hive throughout of face, neck and torso. Unknown the cause, no new cream/regime for face, no new food, and no other new medications. Beside hives and itchiness, no other upper respiratory distress s/s. The hives went away after 30 minutes.

Patient returned to vaccine center approximately 30 minutes after being discharged(initially waited 15min with no symptoms)-upon return patient c/o initial tingling to lips and then itching across face. Treated with 25mg Benadryl, monitored for 40 min. Vital signs remained stable and patient stated that she felt better upon leaving the center.

The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with diphenhydramine prior to the 2nd dose of the OVID-19 vaccine. 9 minutes after the vaccination, the patient felt itchy, flushed and received oral dexamethasone. [atient was sent out with oral dexamethasone home.

Vaccine given 1/15/21, on 1/16 and 1/17/21 reports arm soreness "felt like my arm was being ripped off" on evening of 1/7/21 bad headache, On 1/18/21 symptoms continued and overnight into Tuesday 1/19/21 Temp 101.3 chills and aching body, headache continues.

generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID. The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.

Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.

Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives

Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle aches, chills, intermittent headache and fatigue

Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in right arm, on 21Dec2020 at 19:45, at a single dose, for COVID-19 immunization. The patient's medical history included sciatica. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was a hospital. After the first dose on 21Dec2020 (from the day of injection and for 2 days post), the patient experienced itching, nausea, headache, body ache, and site soreness and swelling. Treatment was received for the adverse events which included paracetamol (TYLENOL) at 500 mg. Since the vaccination, the patient has been tested for COVID-19. Polymerase chain reaction (PCR) nasal swab for COVID-19 that was negative on 04Jan2021. The patient recovered from the events in Dec2020. No follow-up attempts are possible. No further information is expected.

Sore injection site; This is a spontaneous report from a contactable pharmacist (patient). A 26-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 08:45 at single dose on right arm for covid-19 immunisation. Medical history included asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No Covid prior vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient experienced sore injection site on 24Dec2020 12:00. Outcome of event was recovered. No treatment received. No covid tested post vaccination. Information about Lot/batch number has been requested.

26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay.

Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.

Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath and the feeling of pins and needles which also brought itching and some minor hives with it. The dizziness, nausea, and feeling of fainting went away after about 10 minutes and I had to go to the Emergency Department to take care of the shortness of breath and hive like reaction. I was given some medications and they diagnosed it as a moderate allergic reaction to the vaccine. I was completely fine with the first one.

Maculopapular rash presented on neck and jaw approximately 6 hours following vaccination. Slightly pruritic, no other symptoms noted. Resolving at the time of this report, following hydrocortisone cream application - approximate duration of 48 hours.

Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.

all over itchiness, no rash or bumps, intermittently itchy all over body when L arm is itchy, a mosquito bite size bump appears but subsides within 30 minutes after itching area

Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted. Mild anxiety. 25 mg Benadryl po administered. Returned to work at 10:25 am. No reaction to first dose reported.

Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; body aches; low grade fever; First dose on 21Dec2020, second dose on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 05Jan2021 at single dose for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EH9899 on 21Dec2020 07:45 PM, at age of 26 years old, via Intramuscular in right arm for covid-19 immunization and experienced itching, nausea, headache, body ache, site soreness and swelling. Medical history included sciatica. The patient's concomitant medications were not reported. The patient experienced swelling redness and soreness at injection site, body aches, low grade fever all on 05Jan2021 with outcome of recovered in Jan2021. The patient underwent lab tests and procedures which included PCR nasal swab for COVID-19 negative on 04Jan2021. The patient received paracetamol (TYLENOL) 500mg for treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.

Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)

Fatigue for 2 and half days. Increased blurred vision while driving and watching television. Tender at injection site.

Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.

in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a "large mass hard and stiff", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby

Muscle ache localized to the right arm, shoulder and neck. Significant tenderness in R deltoid (injection site).

Pfizer COVID- 19 Vaccine Pt received Pfizer COVID vaccine lot #EL3249. Pt sat for about 10 minutes, arm became itchy, gave diphenhydramine x 1 dose. Pt continued to sit for assessment for another 15 min. Pt stated she felt hot, but is typical for her to feel warm. No chest pain, SOB, blurred vision. Pt cleared to leave facility.

Following 1st COVID-19 vaccination she began having generalized fever, body aches, fatigue, and near syncope prompting her to go to the ED, 2 days after the vaccine. She also began having diffuse swelling of the LUE and L chest wall. Swelling down to elbow prior with erythema and mild rash, which I visualized in a photo. Unsure if blanched. Resolved over several days and was without symptoms when I saw her. Had IV in AC area for IVFs on impacted side but denied symptoms of infiltration.

I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection site right after it was administered. I then experienced severe chills in the evening, starting at about 7pm. The next morning I woke up fatigued and alternated between sweating and having the chills and shaking.

Intense itching palms, soles of feet, axilla, inner forearms, wrists. Lasting from 1/23/21 to present and has not resolved. No change in laundry detergent/soaps/lotions, no known allergies, no medication changes recently.

Patient's reaction(s) noted during COVID vaccine observation period: hives and redness/itching to sides of abdomen. No sob, chest pain noted. Actions Taken: Vital signs taken, observed for 30 minutes. Advised to monitor rash at home and take antihistamines as needed. Patient verbalized understanding. Disposition: Home

Pt presented 24 hours post COVID-19 vaccine (Pfizer) with systemic rash which was pruritic. Multiple lesions on trunk, axilla, groin which appeared pus pustular seen at clinic, prescribed Zyrtec, antifungal cream and hydrocortisone cream. I discontinued the creams and placed on oral steroid burst. still no improvement.

tenderness at injection site; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown expiration), via an unspecified route of administration in left arm on 16Dec2020 at 06:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma and allergy to sulfa drugs. Concomitant medications included albuterol, montelukast sodium (SINGULAIR), and unspecified multivitamin. The patient reported that she has no reaction after receiving the first dose other than slight tenderness at injection site in Dec2020. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 06Jan2021. Outcome of the event was unknown.

A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; woke up with bumps on both of the arms; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 16Jan2021 12:30 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, osteoarthritis, allergies: general anaesthesia. The patient was not pregnant. Concomitant medication included phentermine and vitamin D3. On 17Jan2021 at 10:00 am the patient woke up with bumps on both of the arms. A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives. Patient began to take Benadryl twice a day. On 18Jan2021 at 6:00 am the hives began to appear on both arms again and back. On 19Jan2021 the patient woke up at 6:00 am and the hives appeared on both arms, back, chest, stomach, both legs, neck and parts of the face. Therapeutic measures were taken as a result of rash papular and urticaria which included Benadryl, while no treatment received for skin disorder. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Facility type vaccine was other. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination. Information on lot/batch number has been requested.

Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches

Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, feeling unwell, fatigue.

The patient experienced itching after the first dose of the COVID-19 vaccine.; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), intramuscularly on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching after the first dose of the covid-19 vaccine in Dec2020 with outcome of unknown.

I am a pharmacist for pharmacy and received my first dose of Pfizer Covid-19 vaccine while at work by another pharmacist. Vaccine given around 2:15 PM on 2/2/21 Less than 5 minutes after vaccine - arm tingling at site of injection, arm tingling spread from injection site to fingers, tingling and pins/needles traveled through underarm area and moved across left side of chest, slight chest pain on left side, whole body started tingling, dizziness, racing heart. While experiencing all of these symptoms, I sat on the ground, took two tablets of 25mg Benadryl, drank water, and tried to breath steady to make dizziness go away. Working in this healthcare setting, I was aware I was having an adverse reaction to the vaccine and was prepared with an epi-pen in case of any severe anaphylaxis shock - I did NOT have to use the epi-pen. Less than 15 minutes after vaccine - the chest pain, arm pins/needles stopped, I felt lightheaded still, another co-worker checked my blood pressure which had risen to 178/120 and pulse of 120. About 1 hour after vaccine - still felt light headed, blood pressure still elevated at 158/107, pulse of 107. Around 5:45 PM - After consulting personal friend physicians, I was instructed to go to ER and have an EKG of my heart since my blood pressure and pulse had spiked so high and suddenly. I was able to find coverage at work so that I could leave my shift and get a ride to the emergency room. After 6 PM (admitted into ER) - upon admission blood pressure of 176/117 and pulse of 113

Mild injection site soreness; more tired than usual which extended into the following day; This is a spontaneous report from a contactable consumer (patient's parent). A 26-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 12Jan2021 11:00 to 12Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON). On 12Jan2021, the patient had mild injection site soreness and 3-4 hours after receiving the vaccination and noted being more tired than usual which extended into the following day. The events were assessed as non-serious as per the reporter. The patient did not received any treatment for the events. The patient is not pregnant at the time of the report. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.

small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female patient was administered the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular (left arm) on 17Jan2021 16:30 at single dose for Covid-19 immunization. The patient was administered the first dose of BNT162B2 (lot number: EL0140) on 29Dec2020 at left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient previously took Amoxicillin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 (also reported as "day 6 post vaccine"), the patient experienced small bump at site with redness and mild itchiness. There was no treatment received for the adverse event. The outcome of events was unknown. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination.

Hives all over body, facial swelling, rapid heart rate, itching. Reaction lasted 20-30 minutes. Flu-like symptoms (fatigue, chills, runny nose) followed.

Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature of 99.7

arm pain at the injection site; fever (100 degrees F) later that night lasting into the next day; This is a spontaneous report from a non-contactable consumer. A 26-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EK9231) intramuscularly on 20Jan2021 (at the age of 26-years-old) at 0.3 mL as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received dose 1 of BNT162B2 intramuscularly on 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 00:00, the patient experienced arm pain at the injection site and fever (100 degrees Fahrenheit (F)) later that night lasting into the next day. The patient did not receive any treatment for the events. There was no hospitalization for the events and the reporter assessed the events as non-serious. The clinical outcomes of arm pain at the injection site and fever (100 degrees F) were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

hard large lump that hurts at the injection site /Left arm has a knot in it from injection site; hard large lump that hurts at the injection site; chest pain; shortness of breath; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration into the upper left arm on 05Jan2021 at single dose as a precaution because she works in nursing home (COVID-19 immunisation). Medical history included Covid positive back in Oct2020. Concomitant medication included biotin and one a day women's vitamin. Family members have medical issues. Dad has heart tumors, seizure, sleep apnea and osteoporosis. Mom has asthma, diabetes, has had cancer, neuropathy and macular degeneration. The patient received first dose of the covid vaccine on 05Jan2021 and had some symptoms after the vaccine. On unspecified date in Jan2021, the patient hard large lump that hurts at the injection site, chest pain and shortness of breath; similar to when she had Covid positive back in October. She still has a lump at the injection side which has gotten smaller in size but still hurts to touch. Left arm has a knot in it from injection site; does not reuired ER or visit to physician's office. It feels like a bump with something in her arm. She doubts that is the case. She wanted to see if that was normal and when it might go away, especially since she should be getting second dose on 26Jan2021. She is a speech therapist. There is no prescriber. They came and gave to everyone all at once. It was really big at first. It felt like someone punched her. It was a big giant lump, but it is getting better. The injection was given in the upper left arm and it felt like it went into the muscle. The outcome of the event vaccination site mass was recovering, and the outcome of the remaining events was unknown.

itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; Injection site reaction of redness; Injection site reaction of warmth; Injection site reaction of soreness; This is a spontaneous report from a non-contactable pharmacist (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unknown route of administration in the left arm on 19Jan2021 at 16:30 (at the age of 26-years-old) as a single dose for Covid-19 immunization. Medical history included skin of upper arm is affected by mild eczema/atopic dermatitis, keratosis pilaris, hypertrophic scarring all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to latex which causes a rash/ swelling. The patient's concomitant medications were not reported (did have other medications in two weeks, unspecified). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Jan2021 reported as for first day, the patient experienced Injection site reaction of firmness beneath skin, swelling, redness, warmth, soreness and on the second day also experienced itchiness. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pain was not recovered; pruritus was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Hives, diffuse over body. Intense itching on hands, legs, stomach, scalp, chest, and neck. Would welt up then disappear and then reappear. Start time 3:00pm 2/5/21 and is ongoing. Antihistamines and IM 4mg decadron shot taken. Helped for a time but symptoms have proceeded.

Description of adverse event - Upon disrobing in order to shower for the evening, I noticed a rash, primarily on my torso, but also on my arms. I had not noticed it before this time. I had not noticed itching or any other side effects other than the (expected) arm pain. Treatment - 50 mg of Benadryl Outcome - rash is still present at this time (11:05 PM, Monday 2/8)

Event #1: I experienced a small outbreak of hives on my left cheekbone within 15 minutes of receiving the vaccine. The staff gave me an injection of Benadryl into my right arm. The spot reduced in size over the duration of an hour and I was sent home with instructions to take OTC Benadryl until the swelling disappeared completely later that evening. Event #2: Shortness of breath and chest tightness beginning exactly 74hrs after the vaccination (Sunday, 01/31/2021 at 2:15pm). This side-effect continues to persist and is not due to a true Covid-19 infection.

Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chills and sweats for ~6 hours. 40 hours after dose, woke up and had several painful bumps on vulva and labia- small and white, slight redness around them. No history of STDs, more than a year since last sexual activity. Did some googling to figure out what it was and closely matched what was described/photos in this paper .Searched "aphthous ulcers vulva" to confirm using more photos, and determine treatment/if I needed a doctor, and came across a web site, which then led me to believe they bumps were related to the vaccine. Treated with over the counter hydrocortisone 1% every 12 hours for a total of 4 applications, and bumps are mostly painless and reduced in size.

Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection site inflammation and swelling; This is a spontaneous report from a non-contactable healthcare professional reporting for self. This 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261) on 20Jan2021 10:00 AM at single dose (vaccine location=left arm) for COVID-19 immunisation. Medical history was none. No known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=EL0140) on 30Dec2020 07:15 PM at single dose (vaccine location=left arm) for COVID-19 immunisation. The were no other vaccine in four weeks, patient did not have COVID prior vaccination. Patient was not pregnant. The patient experienced nausea, fever, chills, body aches, lethargy, injection site inflammation and swelling on 21Jan2021. No treatment received. Patient did not test COVID post vaccination. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.

Patient had itching/redness at the injections site (Left arm). Developed hives on the right arm. No itching in throat. Patient was given diphenhydramine 12.5 mg.

Pfizer-BioNTech COVID-19 Vaccine EUA: Patient vaccinated at COVID-19 Vaccine Center. They were brought to observation area and proceeded to have hives and reddening of face, neck and injection site. BLS (EMS) treated patient on site and patient escorted out via wheelchair.

rash going down her arms; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash going down her arms on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

Soreness at injection site as well as anterior shoulder pain. Soreness at injection site resolved., but continues to have anterior shoulder pain.

These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021). Uncontrollable chills, severe body aches, upper/middle back pain, neck pain/stiffness, extreme fatigue, ear aches, raging frontal and occipital headache, and hives (white in color on both legs - inner knee area), itchy neck and chest. Benadryl taken for hives. Ibuprofen taken for other side effects. No treatment/OTC medication provided real relief until late evening of day 3 after vaccine. Hives and side effects resolved entirely after 4-5 days post-vaccine. White hives turned into red healing rash-like bumps and eventually disappeared entirely.

Hives on lips - tiny red bumps on outer edge of top and bottom lips, swollen lips - both top and bottom, both lips bright red

Abdominal rash/hives that is itchy, hives on neck, back and Left elbow crease. SOB with daily activities. Lightheadedness. Symptoms began 3 days post 2nd vaccine and continue to progress.

Chills- night of vaccine all the way through the next day 2/13 Muscle aches & exhaustion- 2/13/21 lasted all day for one day. Required extra sleep + acetaminophen & ibuprofen Hives- Woke up 2/14 will small itchy patches all over the body (shoulders, back, stomach, legs, hands, feet). Took benadryl for treatment. Still itching all day 2/15/21 Sharp chest pain 2/14. Pain started halfway through the day and throughout the night. OTC pain medication had no effect. Disappeared after sleeping and waking up on Monday 2/15 Swollen lymph node in the left armpit (vaccine arm)- slight pain/tenderness. Started 2/14 in the morning. Still slightly tender as of end of the day 2/15

I developed cold urticaria the day following receiving the second dose of the COVID vaccine, I know develop hives when outside in temperatures <37 degrees Fahrenheit and swelling and hives when touching cold objects. I was seen by a doctor who diagnosed this condition, and he believes it is directly related to the COVID vaccine.

I received my COVID19 vaccines on 12/31/2020 and 1/21/2021. On 2/3/2021 I woke up with pain, swelling, redness, and decreased range of motion in my R elbow at the site where I had hardware (wires, pins, tension band) placed during a surgical repair of my olecranon process in 2013. I have never had any issues with this elbow since the surgery, and no illnesses/dental work/medication changes in the months before this. The only change was getting my COVID vaccine. I went to see my PCP Dr. who advised me to go to the ER due to fear of a potential infection based on these symptoms. I went to the ER and after extensive testing they ruled out this being an infectious cause, though I was put on PO doxycycline as a precaution. An orthopedic specialist came to see me and determined that my body is essentially rejecting the hardware and I need to have surgery to have it removed. Since then, the swelling has decreased, however I still have persistent pain in my elbow along the site where the hardware is inserted and limited mobility due to pain with certain movements that put tension on this joint. I will need to have surgery eventually to have the hardware removed but am hoping to wait a couple months so that I can complete nursing school. I was advised to report any potential side effects from this vaccine and am choosing to do so as I do not know of any other reason this could be happening.

Area of red raised bumps in the shape of a square directly below injection site with accompanying pruritus. Onset is not known however, first noticed it 2 days after injection.

Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.

Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.

Pt came in to have 2nd vaccine pt started to notice her arm itching and saw hives PT alerted us and was taken in medical evaluation room where she was given 50 mg of benadryl Pts hives went away with no other reaction Pt left via POV

Orange-ish yellow color appeared on hands (color of iodine) was noticed on Saturday Night 2/20/21 and lump developed above left clavicle noticed Sunday Morning 2/21/21. No treatment was performed.

Patient complained of tingly lips, itchy left arm (near vaccine site). Patient waited 30 minutes with improvement of symptoms and left the site.

Facial hives/hives on the face; might have caused a flare of my kidney disease; might have caused a flare of my kidney disease; This is a spontaneous report received from a contactable consumer (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 27Jan2021 09:45 on left arm at single dose for COVID-19 immunisation. Medical history included liver transplant and kidney disease. The patient previously took amoxicillin and had allergies. The patient did not receive other vaccine in four weeks prior to vaccination but received other medications (unspecified) in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Jan2021 12:00, the patient experienced facial hives/hives on the face and reported that it might have caused a flare of my kidney disease. The seriousness of the events was considered as non-serious by the reporter. Therapeutic measures were taken as a result of event facial hives/hives on the face included Benadryl. The outcome of the event hives was recovering, whereas unknown for other events.

830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.

Slight pain at the injection site; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.

fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering. Information on the lot/batch number has been requested.

I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in my arm within 10 minutes of receiving the shot. I didn't think too much of it because I had some stiffness in my arm with the first shot. But this Friday - March 5th will be a month and I am still having arm issues and they have gotten worse. I never had a rash or bruise on the injection site but from the injection site I have a tenderness on my arm and a constant dull and achy pain - sometimes sharp and painful - that starts at the injection site then travels down through my elbow and into my hand. My hand will get tingly and numb as well. My arm will sometimes randomly fall asleep as well. I went to the doctor but they gave me ibuprofen and that didn't do much. I am going back to the doctor soon.

It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer. Medical history was none. There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.

Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.

headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L arm (axillary region) at this time I have a golf ball sized lymph node in my L armpit that is tender to the touch

hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, limited to arms. itchy but less severe.

Rash on neck and chest that lasted about 10-12 days ? No itching or irritation, just lots of spots. Fatigue.

Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 minutes I had hives on my chest in back. I had high blood pressure 180/120, facial puffiness and mild bottom lip swelling. I developed an onset of increased mucus in my throat causing me to clear my throat frequently. RN on site reported no throat swelling, but increased thickness due to mucus. I received a Benadryl injection on site within 30 minutes and almost immediately symptoms began to lessen. The next day I had mild bottom lip swelling, body itchiness, chest rash, headache and fatigue. Today (24 hours after vaccine) I have a headache, fatigue and body itchiness.

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Intermittent Chills Intermittent headache Intermittent dizziness Fatigue Soreness in arm of injection

Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, very weak and sore arm. Very little movement or strength. Third day, weak but able to slowly lift arm above head.

Increased pain and redness at injection site greater than 24 hours after vaccine. Fevers and chills. Diagnosed as cellulitis, treated with a 10 day course of antibiotics.

Pain and swelling at injection site, muscle of injected arm is achy, hard to lift even to shoulder-height, itching at injection site, body aches, headache, upset stomach/nausea (but no vomiting or diarrhea)

5:28pm received 1st Covid-19 vaccine. At 5:40 c/o slight throat tightness. O2 sat 99, Pulse 100, B/P 128/80. At 5:45pm c/o tongue tingling. 5:49pm hives on chest and c/o chest tightness. Denies SOB. O2 sat 99, pulse 130, B/P 124/72. 5:50pm 0.5 mg Epi administered IM left thigh and EMS activated. 5:50pm pulse 110, B/P 130/82, O2 sat 98%. Transported to hospital at 6:02pm per ambulance.

A week after my shot and I'm still having strange reactions. The day after the shot I started getting really bad cramps and other PMS symptoms like bloating and tenderness (even though I'm on a type of birth control that means I don't get a period). Then a few days later I started my period and has continued. I also have developed the kind of rash that I get when I eat wheat--all over my body and itchy and it hasn't gone done. Finally, it also caused a lot of digestive issues and bloating and gas. it makes me very nervous to get my next shot.

Patient had a minor reaction - reported feeling flush and hives. Patient developed symptoms at 30 min waiting period. She was given 50mg of diphenhydramine and observed for additional time. Patient reported feeling better after receiving diphenhydramine.

Mild/moderate itchiness all over the body set in after a few hours and has persisted to the current time.

Within 8 hours of receiving dose #2 of the Covid 19 vaccine, developed shingles rash on left waist, left lower back and buttock and left abdomen. The rash was red, raised with blisters. She had no fever. She was given Tylenol, and Benadryl to prevent pain and itching. At this point (10 days post vaccine) the rash appears to be healing, blisters have scabbed over and some scabs falling off.

Redness and itching noted after injection. Advised to take PO Benadryl once home. Patient has a history of itching after vaccinations

Within 10 minutes of observation post-Pfizer COVID vaccine. Pt c/o itching to lower back. The RN visualized redness along pant line, approximately palm sized. Waited 5 minutes with continued observation and patient stated continued itchiness but h/o multiple allergies. Denies SOB, no oral swelling noted, RR even and unlabored. Assessed torso with no further significant hives but previous still visible. Pt given 25 mg po Benadryl. Pt requested to go home, denied acute distress, states she has Zyrtec at home. Pt with coworker who stated pt will remain with them for next few hours and they would monitor her symptoms. Pt given s/s to monitor for, when to go to ED if acute symptoms, and to notify MD of possible allergy. Pt agreed with Plan of Care.

The night of the vaccine: body aches 24 hours later: chills, body aches 42 hours later: morbilliform rash on neck, injection site, stomach, and back

103 degree fever, headache, fatigue, muscle and joint pain, injection site pain, chills, fever, and nausea. Developed symptoms starting at about noon the day after vaccination and progressively got worse throughout the afternoon and evening. Symptoms made it impossible to conduct normal activities but have mostly resolved in the second day.

?COVID arm? - red, painful, swollen, hot, itchy skin around injection site, about 3 inches in diameter. Painful to sleep on.

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain tiredness headache stuffiness muscle pain, pain at base of head and top of neck, hip pain, knee pain chills fever (2 days at 100F) nausea dizziness itchiness

I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke up the next day with diarrhea that lasted about 6 days. I had no other symptoms besides dehydration and back pain. On Day 3, I was instructed to take Imodium, which I took for about 2 days, but it didn't help. Around Day 5, I was given fluids, my urine was tested and multiple GI tests were run. I was placed on antibiotics for a UTI. PVCs were also discovered at visit, but it's not connected to the vaccine.

Patient described itching and rash on skin. She would scratch her skin and break out in hives where she scratched. The itching would intensify and then go away and move to a different area of her body. 80% of the itching is on her back, neck, shoulders, and legs. She shared that the injection site is unremarkable. At time of call, she was trying to get a hold of her health care provider.

Sore throat starting the next day possibly connected to the high pollen count rash no itching just warm and red skin

Monday I received the vaccination (1st of the 2). Tuesday I started seeing bruises on my right side (I was vaccinated in my right arm). I can see 5 bruises. 1 on my right arm. 4 on my right thigh. All are various shapes (dime sized to quarter size) but they are all more of a darker yellowish bruise. I did test positive for Covid back in November 2020 and didn't need any medical treatment. I was told that 90 days out was okay for receiving the vaccination.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Medium

I developed a rash ten minutes after receiving the second dose. On my neck and it trailed down to chest area. They took me to Urgent Care and they gave me Benadryl and the Rash went away.

Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.

Fever, chills, body aches, muscle and joint pain, nausea, vomiting, diarrhea, trouble concentrating , headache. These symptoms lasted about 30 hours. Headache, trouble concentrating, pain at injection site have lasted almost 48 hours and continue to exist but have been reduced over time

Less than 3 minutes after administration, I began having tingling in my throat. My heart began to race. I grabbed a medically professional who assessed me, she stated I was beginning to flush and then had EMS respond. Vital signs indicated a peak heart rate in the 160?s, O2 Sats were in the 80?s. I also had a metallic taste in my mouth and a tightness in my airway. Later in my hour observation I had a period of facial flushing and itching. I had ice packs placed on my skin, given a fluid bolus and monitored by an RN and EMS personal. A Doctor assessed me and contemplated transporting to the ED for management but I was slowly feeling improvement. I was monitored for an hour and felt okay when I left the clinic.

Employee reports after second dose onset on chills, and soreness to injection site. sxs resolved on own. Employee reports having both Pfizer vaccines 1st dose 12/23/20, 2nd dose 1/12/21. Employee became symptomatic and tested Covid positive 3/25/21. BWH Infection contact tracing team has identified the employee as contracting Covid by a Community Contact. Employee quarantining at this time.

Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.

I developed a Severe rash (blotchy, red, itchy ) all over both arms and back 36 hours post 2nd dose Pfizer vaccine. I had a high fever of 103 and massive headache too and body aches

After receiving first COVID vaccine patient reported tasting metal, itchiness in right leg. Patient was monitored for an additional 10 minutes, no additional symptoms were noted during while being monitored.

About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; My throat was also just a little bit tight and breathing was labored/Little tightness around the throat; My throat was also just a little bit tight and breathing was labored; allergic reaction; rash all over my face; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at the age of 26-year-old on 07Apr2021 14:40 (Lot Number: 7131121) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included lung transplant from 2016 (recipient of double lung transplant in 2016), Slight damage to the windpipe, Asthma, immunocompromised. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone; metoprolol; magnesium chloride. The patient previously took cefdinir (OMNICEF) and experienced drug allergy, clarithromycin (BIAXIN) and experienced drug allergy. Patient got her shot at 2:40 pm. Seemed fine, waited at the star for 15 minutes and went on her way. About an hour after patient looked in the mirror and saw that her entire right cheeck was bright red, hot, and itchy on 07Apr2021 15:30. Her throat was also just a little bit tight and breathing was labored on 07Apr2021 15:30. Patient went to the emergency room and was given 25mg of oral Benadryl, 20mg of famotidine, and a dexamethasone shot. Patient was then observed and released once her reaction started to calm down. Consumer stated, she was calling because she had a allergic reaction to her first dose of the Pfizer Vaccine yesterday (07Apr2021). It did occur just after half an hour of the Vaccine on 07Apr2021 15:10. She broke out in a rash all over her face in Apr2021. Little tightness around the throat. Therapeutic measures were taken as a result of 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored'. Adverse events 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored' result in Emergency room/department or urgent care. The outcome of events rash all over my face and allergic reaction was unknown. The outcome of other events was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.

I received my second dose of Pfizer around 3pm on Sunday, April 4 2021. By about midnight, I had a fever and the fever/headache and exhaustion persisted throughout Monday. I did not take any medicine. By Tuesday morning, my fever broke, but I developed a large 6 inch rash under my left armpit (my second shot was in my right arm as I am left handed). By Tuesday afternoon, I had developed a bad cough. Given that I work remotely, and had only been to a grocery store (double masked) with my mother a few days prior to the second dose, I assumed the cough was a result of the second dose. My cough become worse, and by Wednesday it sounded like bronchitis so I went to my doctor. She believed that it was a bronchitis cough, had me tested for viral infections, and put me on a variety of medications from antibiotics to steroids and inhalers. I tested negative for all the respiratory illnesses I was tested for, as well as COVID-19. The medications did not seem to help, and my doctor added another inhaler and medication to the mix. After about 2 weeks of medications and no improvements, my doctor had me get a chest X-ray to make sure I didn?t have pneumonia or any other obstruction in my lungs. I also stopped all medication on Tuesday, April 20. My chest X-ray came back clear later that week, and I decided to just stay off all medications and hope that my body would self heal, since this seemed to be a self created bronchitis, as my parents did not get sick. Finally, after 2 weeks and 4 days, my cough has improved significantly to the point where I can now talk almost normally, without going into coughing spasms and feeling as though it was difficult to breathe.

Severe headache, sinus congestion, dizziness, nausea, diarrhea, heavy menstrual period, fatigue, drowsy, muscle pain, injection site soreness

10 minutes after shot throat was itchy, 30 minutes after shot throat was more itchy and broke out in hives across chest and outside of throat

Exactly a week after receiving the shot, a bright red welt appeared on the injection site. It was hot to the touch, hard, tender, and was itchy if scratched. It stayed hard, tender, bright red, and hot to the touch for three days before disappearing on its own. Having taken the second shot over a week ago, the welt hasn't reappeared. If you want to reach out to me, I have photographs.

I had a couple of bruises to pop up but I didn't known if I hit my leg on something or not. Still this is the longest I've ever had bruises to last on my leg. It feels over worked. Also, my body feels shaky sometimes. I'm not sure if it's my nerves since I just lost someone close to me or from this shot. I've never felt shaky at random like this. It feels like my heart races when that occurs, too. It never last long, either.

I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.

shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylenol/Benadryl. Advised f/u in UC or ED for any new/worsening symptoms of any kind

Patient started develop itchy rash on arm near injection site. The diameter of the rash was about 4 inches and developed in about 20 minutes after injection. We gave her an ice pack to apply over the area and a tablet, crushed of Benadryl.

The Sunday after I received the vaccine I had increased hip pain and Sunday night I had a rash anon the L2 and L3 dermatome. I thought it was shingles and made an appt. Overnight the rash spread and it was very painful, On Monday I got Volcite for 7 days and I still have rash (improving) and pain today.

received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00

Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.

12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.

Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.

I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.

I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.

Patient developed acute pain, itching and warmth at site of vaccine administration. She developed a rash extending to the top of the LEFT shoulder into the LEFT earlobe

sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.

Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.

Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021

Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.

Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.

Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches

Hives; This is a spontaneous report from a contactable other health professional. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021, NDC number: 5926710001), via an unspecified route of administration on 30Dec2020 08:11 at a single dose in right bicep (right arm) for COVID-19 immunisation. Medical history included urinary tract infection from 21Dec2020 to Dec2020 which was resolved and fine after the antibiotic, ongoing eczema (had this condition basically her entire life), ongoing sensitive skin (always had pretty sensitive skin). Concomitant medication not reported. The patient previously took nitrofurantoin (MACROBID [NITROFURANTOIN]) from 24Dec2020 to 28Dec2020. The patient experienced hives on 01Jan2021 09:00 (also reported as "got it last Wednesday morning and broke out in hives the next day"). Patient stated, "I have a question to you. I got the Covid Vaccine, the Pfizer Vaccine on Wednesday morning like around 8 o' clock and this morning I woke up and I broke out hives. I didn't know if in two days, I just want to report my symptoms just to make sure everything is okay." The hives were bad on Friday and took Benadryl and Cortisone cream and it is better now. The hives are not worse; not as bad as it was on the first day. She took about 5 Benadryl throughout the first day: 01Jan2021. Over the last few days she has continued to get small breakouts of hives on pretty much every single spot on her body except for her face; the hives seem to kind of take turns in different areas of the body but have not gone away. She has used Hydrocortisone, lotion and Benadryl for the hives. The outcome of the event was recovering. She is both a sonogram technologist as well as the patient. She asked if she should or should not receive the second dose of Pfizer COVID- 19 Vaccine in response to the hives. She is supposed to get second dose on 19Jan2021; unknown if she will or will not change dose scheduling in response to event at this time.

I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.

injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration.

lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.

Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.

side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F. side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.

Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***

I had redness injection site and little rash. I notice little red spots. The 2nd day I receive bumps on both arm, which was very itchy. The 3rd day my whole body was fill with the bumps. The bumps lasted for a week.

Medication was administered subcutaneous not intramuscular. Cellulitis occurred, site was warm, red, swollen, painful and hard. Was prescribed keflex by ID DR on Saturday, 1/9/2020. Site continued to grow until Monday, 1/12/2020.

Once I receive the shot; my arm became red. I start seeing red bumps around the area I receive the shot. My next day I had itchy bumps on both arms. By the 3rd day my whole body was covered with bumps. That lasted for a week.

Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present. 50 mg oral Benadryl taken an hour after vaccination.

Patient complained of itching dermatitis throughout torso and face with visible hives. Patient complained of throat "feeling funny". Patient immediately transported by wheelchair 300 ft to ED.

Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatigue, severe headache, muscle pain, fever x 8-10 hours (started about 10 hours after getting the vaccine), Tylenol

Urticaria; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular on 18Dec2020 at a single dose on the left arm as vaccine. Medical history was not reported. There were no concomitant medications (did not receive other vaccines within four weeks to the COVID vaccine and did not receive other medications within two weeks of vaccination). The patient had no known allergies to medications, food, or other products. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The patient experienced urticaria on 18Dec2020 assessed as non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not pregnant at the time of vaccination. She was not diagnosed with COVID-19 prior to vaccination. She had Covid tested post vaccination (had been tested for COVID-19 since vaccination)- nasal swab result negative on 31Dec2020. Treatment for the event included Benadryl. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.

body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.

developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolved

immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness she says. on questioning if BP was checked, she said BP was not checked. Denies ever getting lightheaded or dizziness with other types of vaccinations or immunizations so probable not vasovagal. Headaches she also reported arm aching at this vaccination site. initially said in 1/2 hour later she says 2 hours. She looked at the vaccination site on her arm for first time 8 hours after this vaccination. Found redness and blisters first time treated with diphenhydramine 5 mg. barely move arm next day. swelling arm lasted 2 days. photos of arm vaccination site she sent were reviewed. had video visit with Family Medicine Physician and later with video visit with Allergy Physician

Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch. Moments of Dizziness and zoning out.

PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.

Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection site, body chills, body aches and a fever of 102 F. Symptoms subsided after Motrin was administered (in about an additional 8 hours to recover fever). Body aches, pain at injection site and lingering headache still present 24 hours after vaccination.

left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.

rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over; a lot of muscle pain; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 24Dec2020 09:30 at single dose for preventative. Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization and experienced sick (Flu shot if it contains egg she gets really sick). Patient reported experiencing a rash 2 weeks on 06Jan2021 after getting her first dose of the vaccine. Caller stated ''I'm concerned because I'm getting this rash on my face and everywhere and I'm due for my booster on 13Jan2021." Caller questioned if others had reported this. She had a lot of muscle pain on 24Dec2020 and could not sleep from the pain in Dec2020. Reports the pain is gone now and lasted till 28Dec2020. She has a rash and it is breaking out her face and now it is all over. States nothing has changed and the vaccine was the only new thing. States the rash started two weeks since she got the vaccine. Vaccination facility type was Hospital. Vaccine administered at military facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE not require a visit to emergency room. Therapeutic measures were taken as a result of rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over (Doctor ordered steroids for her today she is a CNA). The outcome of the event a lot of muscle pain was recovered on 28Dec2020. The outcome of the event rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over was not recovered. The outcome of the event could not sleep was unknown. Information about lot/batch has been requested.

After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm soreness at the injection site. Later in the day, I experienced fatigue, which progressed to body chills and aches. Overnight, I developed a fever of 101.5 F. Fever was managed with ibuprofen taken throughout the following day, 1/13/21. On 1/13/21 at night, I had another fever of 101.6 F but did not taken any antipyretics before bed. On the morning 1/14/21 body aches, body chills, and fevers were resolved without antipyretics. Arm soreness still present on 1/14/21.

Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulates. Administered Benadryl 50mg PO. symptoms persist after 20min. Called 911, evaluated and transported to Emergency Dept.

My injection was at 4:08 pm on 1/13/21. I woke up from a dead sleep at 2:30am on 1/14/21 and started vomiting for about 20-25 minutes. Also muscle pain at injection site.

Patient reported having a rash/itching hands and feet about 2days after the vaccine. Took Benadryl 4 times a day and resolved two days later. was told to contact primary care physician before getting the second dose

injection site pain; This is a spontaneous report from a non-contactable pharmacist (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730, expiry: unknown), via an unspecified route of administration on 17Dec2020 12:00 at single dose (Left Arm) for COVID-19 immunization. Medical history reported as none. Patient had no known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. Other medications within 2 weeks of vaccination was reported as oral contraceptives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Only adverse event related to first dose was injection site pain from an unspecified date. The outcome of the event was unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.

redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on 07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl

After administering the first dose, patient became itchy and blotchy all over body. At 11:04am gave patient Benadryl 50mg. By 11:12am redness was going away.

Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better

hives after first shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration, the first dose on 15Dec2020 (lot number: EH9899) at a single dose, then the second dose on 08Jan2021 (lot number: EK9231) at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient experienced hives after first shot on 15Dec2020. No treatment received. Outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.

Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM, EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight stridor, EPI IM, Solumedrol IM, EMS transported to local ED. Patient called NP later in day and said she was admitted to the hospital.

Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.

Vaccination was on Wednesday: about a half hour after vaccine, I experiences increased heart rate, vision going black like I was going to pass out, it passed in about 5-10minutes of laying down; also had metallic taste in mouth the rest of that day. Thursday I just felt red, itchy, swollen L arm due to vaccination site. Friday morning my bottom lip was severely swollen with numbness and tingling. It went down by the next day and after taking Benadryl. I have not had an allergic reaction to anything in my life before. Was instructed to not get second vaccine as I may have a more increased reaction to it.

When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.

About 10-15 minutes after vaccination, patient reported that she was feeling dizzy and was breaking out in a rash. Upon examination, a maculopapular rash was observed on upper chest and arms. No localized symptoms at injection site were reported. No breathing abnormality was reported. Patient was placed under further observation and vitals were taken by RN at facility (BP: ~113/100, HR: 105). Patient was observed for another 15 minutes, patient reported her dizziness was still present, rash was not worse at this time. No breathing abnormality was reported at this time either. Medical services (which were called for a different patient) also evaluated this patient and the patient was then taken to local ED for further evaluation.

Arm pit sore - to injection site, warm to touch, red area, tender to touch, swollen denies any fever Started on abx - cephalexin

Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. Then I became dizzy and pale. I was laid down and vital signs were taken. My heart rate was in the 110s and 120s and stayed elevated for about four hours. The hives resolved and did not spread to the bilateral arm or anywhere else. The following two days I felt incredibly weak and had urinary frequency. I was told to go to the hospital by the health clinic staff but I declined.

Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redness of bandaid mark 3 days later with multiple washes.

injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.

tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report from a non-contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration (left arm) on 01Jan2021 10:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that immediately after receiving vaccine (01Jan2021), the patient felt tingle in throat, severe left arm pain, dizziness, weakness, and migraine. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. No further information is expected.

1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride

I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I began having urticaria all over my body. I took Benadryl 4 times over the course of the day, and the rash goes away but comes back. Went to Urgent Care on Sunday. Advised to take Benadryl and Pepcid

Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%

30 minutes after vaccine pt developed rash on arms and had tingling in right arm. No other symptoms. Gave 1 dose of 50mg benedryl and within 15 minutes the tingling had stopped and the rash went down. Monitored for 30 minutes and the pt was then released.

Chills, fever, body aches, headache started about 12 hours after injection. About 24 hours after injection I developed a rash and swollen lymph nodes on the arm the shot was given to me

Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021. Information on the lot/batch number has been requested.

First started off with a cold feeling around injection site. Around 11:30 at night I felt muscle aches in my calves. 30 minutes later my legs were having severe muscle aches and joint pain in my ankles. I was having cold chills and aches the whole night along with sweating. On 1/20/2021 (the next day) the muscle aches, chills, and joint pain continued through the whole day. I was nauseous at times and did not have an appetite. Around 5 o clock I felt some relief with my leg pain but it started again around 9 o clock. I continued switching Tylenol extra strength and ibuprofen. I went to bed on 1/20 at midnight with little leg pain but major neck and back aches. I did not have cold chills through the night or sweating. Today (1/21/2021) leg pain is near gone, but joint pain is still there in my left ankle and knee. My legs feel heavy and strange and is causing me to walk slowly because I feel like my legs are very fatigued and off balance. I have had neck and back aches all day. I have not had chills today

I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I received the vaccine I noticed some injection site tenderness, minimal swelling; has been present since. Symptoms are very mild. I started having chills and hot flashes intermittently, more hot flashes than chills, have been present since 6pm yesterday. About 9pm I had a headache, muscle aches, joint pain as well. I felt feverish but temperature was 98.6F. I also noticed some axial lymph node swelling as well on the Left side where I received the vaccine. Tender to touch, not too painful though. Since received the vaccine I have had intermittent dizzy spells as well all throughout the day. I decided to go to sleep at 10:30pm and all night I tossed and turned with a headache and hot flashes. I woke up at 7:30am and was so stiff I could barely get out of bed. I called into work as I could not stand up without have dizziness. All day so far I have had dizziness upon standing, headache, myalgia, arthralgias, hot flashes/felt feverish, swollen axial lymph nodes and all I have wanted to do today is sleep. I took a nap and when I woke up I had been sleeping for 6 hours. I finally was able to get up and drink a 32ounce cup of water and take some ibuprofen. Ate some cereal. I still have a headache and dizziness upon standing that limit my ability to do normal daily functions.

Patient reported swelling of lymph nodes in armpit, inflamed injections site, pain. Recommended icing the area, take diphenhydramine and some Tylenol and/or ibuprofen for pain and inflammation.

Rash on upper body; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2, intramuscularly in right arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were unspecified. On 10Jan2021 15:00, patient experienced rash on upper body. Treatment was not received for this event. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.

Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/2021. Rash erythematous and raised with no hives. Rash started on chest and has spread to bilateral arms, bilateral legs, and back. Face, palms, and soles spared. Reports cough and shortness of breath for an hour when rash first appeared that resolved and has no returned. Since rash has started has taken OTC Benadryl every 6-8 hours. Patient presented on 01/22/2021 for evaluation of the rash.

Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on the chest and then spread to the bilateral arms, bilateral legs, and her back. Her face, palms, and soles are spared. Rash is mildly pruritic and not painful. Patient reports at the time the rash started she had a cough and SOB for 1 hour that has resolved and not returned. Patient has been taken OTC Benadryl PRN every 6-8 hours since the rash presented. Patient presented to Clinic for evaluation on 01/22/2021.

Pfizer-BioNTech COVID-19 Vaccine EUA: Approximately three days after vaccine administration patient developed itching and redness of face and body. Went to urgent care and prescribed hydroxyzine which patient took and immediately relieved symptoms. No other medications administered and no other symptoms reported.

Had itching at site immediately rash above site developed later in the day. About 10 minutes after injection developed nausea then felt very hot became clammy and sweaty. Felt lightheaded became pale had to played down on the ground.

I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about 20 minutes, I developed a burning sensation at the injection site. Approximately 30 minutes following the vaccine, I began experiencing an intense itching and hives of my opposite forearm. Then shortly after, my shins and front of ankles started itching. I began getting little bumps with an itch to several other areas of my body, also including redness and itchiness of one side of my face. At about 40 minutes, I also experienced a cold sensation felt at the injection site, almost like what it feels like after removing an ice cube from the skin. The itching of my skin on several areas of my body persisted for about an hour and a half. The welts and itchiness almost completely subsided at about the 2 hour mark. I did take two benedryls once I got home which was about an hour and a half after the injection. Today, the following day after injection, the bumps and itchiness are still no longer present. I have been experiencing a very sore arm at injection site and extreme exhaustion today though.

Within 5-10 minutes of receiving the vaccine my heart starting racing a little bit, I got a little light headed, and had a weird taste in my mouth. The morning after my vaccine (1/22/2021) the Injection site of the vaccine is swollen, hot to the touch, and red/hard. The following day (1/22/2021) around 3:45 pm I broke out in a rash on my face and neck

Nausea (2-3 days) Constant headache Swelling in injection site Redness at injection site Feeling unwell

Two hours after the vaccine was given, I developed a headache and the injection site was sore. I treated it with ibuprofen. Approximately 48 hours after the vaccine was given, I experienced a sore throat and fatigue that has lasted for two days and counting.

Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.

Red rash on my face about 24 hours after initial dose- went away with Benadryl Rash was itchy and blotchy

sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 12Jan2021 16:30 at SINGLE DOSE at Arm Left for covid-19 immunisation. Medical history included covid-19; covid prior vaccination: yes. Concomitant medication included escitalopram oxalate (LEXAPRO). Major hair loss starting 1.5 days following the vaccination on an unspecified date in Jan2021, in addition to sweating, chills, fever, and major fatigue on 13Jan2021 22:30. The patient did not receive treatment for the events. The outcome of the events was not recovered.

Previously enlarged lymph node (after first COVID 19 vaccine) became larger and red for 3 days. It then went back down to the size it was after the first injection.

swelling at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; body aches; fatigue; fever 100.2; This is a spontaneous report from a contactable Nurse. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), intramuscular on 13Jan2021 10:45 at single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included covid-19. Historical vaccine included first dose of BNT162B2 lot number EK5730 on 22Dec2020 10:15 AM. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), cetirizine hydrochloride (ZYRTEC). The patient experienced body aches on 14Jan2021 05:00, fatigue on 14Jan2021 05:00, fever 100.2 on 14Jan2021 05:00, pain, itching, redness, warmth at injection site on 15Jan2021. The patient underwent lab tests and procedures which included body temperature: 100.2 on 14Jan2021, and 99.8 on 15Jan2021. No treatment received. The events recovered in Jan2021.

Local skin allergic reaction at the injection site; Swelling (about the size of a quarter) at the injection site; Red dots (about the size of a pencil eraser) that appeared around the injection site; some spots around the area approximately the size of pencil erasers; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), intramuscular in the left upper deltoid muscle, on 13Jan2021 at 10:30, at a single dose, for COVID-19 vaccination. The patient had no medical history and concomitant medications. On 13Jan2021, the patient received first dose of vaccine and immediately (about 5 minutes after she received the vaccine at 10:35) developed non-severe local skin allergic reaction and swelling at the injection site, and some spots around the area approximately the size of pencil erasers. The patient had swelling (about the size of a quarter) at the injection site, along with red dots (about the size of a pencil eraser) that appeared around the injection site. The patient's vital signs were normal, her breathing was fine, and she had no swelling in her throat or lips. The patient took diphenhydramine hydrochloride (BENADRYL) 25 mg tablet, and a minute or two after taking the diphenhydramine hydrochloride tablet, all the symptoms went away. The patient was calling to see if she should receive the second dose of the vaccine. The patient asked if she should get the second COVID-19 vaccine dose, based on her adverse reactions after receiving the first dose. The patient recovered from the events on 13Jan2021.

While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling, and tingling of tongue and lips. Redness was in face, chest and right arm. Client denied difficulty breathing or throat tightness. Client reported at this time "significant hx of anaphylactic reaction." This was not noted clearly on screening form signed by client. Client given 50 mg Benadryl per standing order due to symptoms. Epinephrine was not given. 911 was called. Client vitals remained stable with slightly elevated blood pressure ate 140/102. EMS arrived before repeat vitals were taken. Lung sounds were clear and equal bilaterally. Report was given to EMS and care transferred.

Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.

?Pfizer-BioNTech COVID-19 Vaccine EUA? Pt had red streaking to arm near injection site approximately 10 minutes after injection, then also had chest tightness and felt like her voice had changed. Was given 50mg of benadryl by EMS with near immediate improvement of her symptoms but pt referred to ED. Pt arrived at ED and felt improved, no redness noted to site, no hives or rash noted on exam. Discharged home

I started breaking out in hives/rash on January 27th at church. I was itching all over. I took a benadryl to help. Since then I have continued to break out in spurts. The site will start itching on my body and not stop until I itch it, then it goes away and pops up somewhere else. I have not changed laundry detergent, eating habits or environments. The only thing new to me would be the vaccine. with it being almost 8 days onset from vaccine, I didn't think that would be the problem. I can't figure it out though. I spoke with Doctor this morning and she said it was best to report because it could be an adverse reaction.

Patient sitting in chair of observation area. Suddenly felt dizzy. Observation staff RN brought patient to triage. Patient states she felt dizzy. Lightheaded, nauseated, started vomiting, vomited two times. Slightly diaphoretic. She is warm and dry BP elevated. Patient started to scratch back, lower and mid back. noted with scattered raised red rash. Patient drowsy and altered mental state gave Benadryl. Patient to triage cot, cold pack applied V.S and N.S. measured. Charge nurse present. Benadryl 50mg IM given per protocol. EMS activated. report given to paramedic crew. No further vomiting. V.S.S. SR on monitor O2 sat 99%. Remains orientated to name, place and date. Cannot open her phone or recall family emergency number. Patient sent to hospital with EMS.

Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt like she was running a fever but was not. She was hot and cold during the night; it burns; felt hot and cold; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 at single dose at left arm for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. On 17Jan2021, the patient experienced skin feels like she rubbed icy hot all over her body, like if she scratched or touch it, it burns. There is no redness or rash. Her work just sent her home because she is required to wear an N95 mask. Her breath against the mask makes it feel like her face is on fire and she cannot wear it. She felt like she was running a fever but was not. She was hot and cold during the night, but her temperature was 98 degrees Fahrenheit. She just took Benadryl and they sent her home. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination. Information on lot/batch number has been requested.

two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 13Jan2021 at 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. The patient has no known allergies. Concomitant medication included topiramate (TOPAMAX). The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient had two inches of redness and swelling at the injection site that is tender to touch. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.

vaccine administration error- left deltoid injection site bleeding moderately immediately following administration, the bleeding stopped with approx 30 seconds of pressure to site. No other adverse reactions. Evaluated by the medical provider at the site and injection appeared to be in the correct area.

All over body hives with severe itchiness, medicated with Benadryl, took 2 doses of Benadryl and still feeling itchiness and hives. Symptoms started around 10 am and lasted all day

Moderate rash for 24 hours, headache for 24 hours and fever for 48 hours along with nausea, additional notes not sure if rash is due to shrimp allergy

the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 10Jan2021 at single dose for COVID-19 immunization; and diphenhydramine hcl, via an unspecified route of administration from an unspecified date at unknown dose for premedication. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2, lot number: EL0140, via intramuscular in left arm on 20Dec2020 at single dose for COVID-19 immunization and experienced itching. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was pre-medicated with diphenhydramine prior to the second dose of the COVID-19 vaccine. 9 minutes after the vaccination on 10Jan2021, the patient felt itchy and flushed then received oral dexamethasone as treatment for the events. The patient was sent out with oral dexamethasone home. The outcome of the events was recovering. The action taken in response to diphenhydramine hcl for the events was unknown.

Fever 99.9; body aches; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at left arm, on 22Dec2020 10:15 at single dose for covid-19 immunisation. Medical history included having COVID prior vaccination. Patient has no known allergies. Patient is not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamins nos (MULTIVITAMIN). Patient did not receive other vaccine in four weeks. Patient experienced fever 99.9, body aches, Injection site tenderness, swelling, redness x 10 days, all on 23Dec2020 08:00. No treatment received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered.

Scattered Diffuse erythematous plaques ~ 5 days after receiving second Pfizer vaccine + with systemic body aches. Treated with topic steroid and PO steroids

Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient (unknown if pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left arm on 23Jan2021 13:15 at single dose for covid-19 immunisation. Medical history included Migraines with aura, vasovagal syncope, PCOS, environmental allergies/hay fever, eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cefixime (FLEXERIL), ibuprofen (ADVIL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), inositol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site, muscle pain, fatigue, dizziness, all on 23Jan2021 1400. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.

The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp before taking antifebrile medication at 100.8 F. At the site of injection on my left arm there was a red mark and slight swelling, left arm felt weak and sore. Overall sense of unwell lasted for two days.

Client upper arms flush red and chest. Is complaining of feeling warm and headache. EMS evaluated Bp122/90, lung sounds clear. Instructed to either see PCP or go to ER. Client called Dermatologist and showed her doctor her chest in between EMS check. Derm. doctor instructed her to take benadryl Client to be driven home by family. Instructed if does not improve with benadryl to go to ER.

Muscle sore and itchy around injection site. No redness. EMS evaluated and removed band aid. Had client do arm stretching exercised and felt better.. BP 120/82 P72 O2 98% lung sounds clear

Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swelling began near elbow, redness and pain followed and immobility. Visited ER on 2/3/21 and diagnosed with superficial thrombophlebitis

After second dose pain at injection site; chills; diarrhea; GI upset; unwell feeling; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration left arm, on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No reported allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered as at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant at vaccination time. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 on the left arm. The patient experienced after second dose, pain at injection site, chills, diarrhea, GI upset, and unwell feeling on 20Jan2021 21:00. No treatment was given for the events. Outcome of the events was unknown. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

Rash on inside of elbow on same arm as injection; This is a spontaneous report from a non-contactable consumer report for self. This 27-year-old not pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm on 20Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced rash on inside of elbow on same arm as injection on 22Jan2021. Event recovered on 24Jan2021. No follow-up attempts are possible. No further information is expected.

Within an hour, I was having severe pain in my shoulder. I took off the bandaid and noticed the injection point was way higher than it should have been. I had redness in the area (about 1-1.5 inch diameter) too that I have a picture of to show the injection location. I have limited range of motion, severe pain, and shooting pain down the back of my arm. I am unable to use my arm or lift anything that has any weight to it.

Hives on arms, appeared 10 minutes after injection. No breathing issues. Dosed two 25mg diphenhydramine capsules. Pt had no hives 1 hour later. Told to follow up with emergency department if hives returned

Patient stated that had an itchy throat and developed a rash through the body. She also reported itchiness through the body.

Rash to face started 2/9/21 evening incontinence of urine, 2/9/21 overnight nausea, stomach pain 2/8/21 daytime/afternoon

Very intense itching all over the top of my scalp; This is a spontaneous report from a contactable consumer reporting for self. This 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) on 20Jan2021 at 9 O'clock in the morning at single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety depression. The patient previously received oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and experienced intense itching. The patient experienced very intense itching all over the top of her scalp for about an hour (as reported) on 20Jan2021 at 2 O'clock in the afternoon. Patient did not receive any treatment, it did go away on it's own, and only lasted about 2 hours (as reported). The outcome of event was recovered on 20Jan2021.

first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info

Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the night that traveled up my forearms. On a scale from 1-10 the pain was about a 7. After the first dose, the pain went away in the morning and I was fine. On the third day after the second dose, I woke up with a rash all over my body and again had pain throughout the night only this time I woke up with swollen hands. It?s now been two weeks since my second dose and I am still experiencing hand pain, though improving. My hands feel sore and tight.

Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.

8/10 pain at the injection cite. Started 12 hours following the vaccine administration and resolved around 24 hours following administration of the vaccine.

3:30 Rash w/ 25mg of Benadryl. Director of nurses observed rash; Observed til 4:30 - reviewed with director of nurses - was fine to go home

Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade on the side where the vaccine was injected). Painful sunburn sensation for the first day or two after presentation, but has lessened to more of an irritation 11 days later. Definitely still present though. No visible rash or marks.

Patient had onset of blistering to ears, armpits, back of legs and groin. Patient decided to not get 2nd dose after reaction to 1st dose.

8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak began on the left forehead with ocular migraine and hypersensitivity of the left medial portion of the face. Valacyclovir 1000mg TID x10 days was initiated within 24 hours of onset, and rash continued to progress down the face to the left eyebrow, left nostril, and left upper lip. Pain and hypersensitivity of the left upper jaw and teeth began on day 3 of zoster outbreak, and ocular migraine increased in intensity. The rash began to blister on day 4, and is continuing to blister and weep currently (day 5).

Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature usually <97). Severe chills onset around 9:30 pm. Mild Soreness at injection site starting approximately two hours after vaccination.

Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 20, Administer Epi injector right thigh. Given IM Benadryl. Transported to ER.

Rash appeared on the trunk, small red maculopapular spots, bright red in color, slightly itchy, with clusters of a few at each spot. Majority of the spots appears within the bra line of the patient, started about a week and a half after the first done (1/22/21) but became increasingly worse two days after the second dose (was received on 2/12/21). First there were many more on the trunk with some patches increasing in size and rash starting to appear on arms and legs as well. Tried benadryl, fexofenadine, and hydrocortisone which helped minorly. Sought medical advice in the clinic (5 days post second dose) and couldn't identify other source of rash (no new product, no bugs bites, etc). Was prescribed triamcinilone acetate cream to help relive itching and redness, which as of 2/24/2021 is improving slowly.

I have an itchy rash all over my body; little white bumps; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient (not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number; E19269) via an unspecified route of administration on right arm on 03Feb2021 18:30, at single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included unspecified birth control within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she had an itchy rash all over her body, they were little white bumps on 04Feb2021. The patient was not received any treatment for the events. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Seriousness of the events was assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.

I received the 2nd dose of the Pfizer COVID-19 vaccine around 9:15 am on 2/23/21. Initially, my only symptoms were injection site soreness and minor swelling. Gradually throughout the day, my entire left arm become more and more sore. By 5:00pm, I felt exhausted and dizzy and was having chills. My temperature was 99.8 degrees Fahrenheit. I took a dose of Extra Strength Tylenol, but felt no change. My joints and muscles began to ache around 6:00pm on 2/23/21 and did not stop aching until around 9:00pm on 2/24/21. During the evening of 2/23/21, my dizziness increased and I felt as if I would pass out any time I sat up or stood. My temperature had returned to 98.2 degrees Fahrenheit by 10:00pm on 2/23/21. I then took a dose of Motrin to help with my soreness. On 2/24/21 from morning until 8:30pm, I had no fever or chills, but still felt exhausted and had minor muscle/joint achiness. I took 3 doses of Motrin on 2/24/21 to help with the soreness. Throughout the day, I had some difficulty breathing (felt like a mild asthma attack) and used my emergency inhaler once. At 8:30pm on 2/24/21, my temperature was 100.5 degrees Fahrenheit. I took another dose of Motrin and went to sleep. Around 3:00am on 2/25/21, I woke up drenched in sweat, but feeling better. My temperature was normal then. When I woke up at 7:00am on 2/25/21, I no longer felt achy, dizzy, or tired. I still feel (now at 1:30pm on 2/25/21)as though my asthma is aggravated, but am not having difficulty breathing.

Dermal Hypersensitivity after 1st dose on1/21/2021. It got better and then I had the 2nd dose on 2/14/2021 and it is back

Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.

anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, nausea, dizziness,

Persistent and painful lymphadenopathy in left armpit that started T+36 hours after vaccination. At 7 days after administration of the vaccine, lymphadenopathy in left armpit persists and remains painful. At 7 days post vaccination a 2 inch patch of swollen skin appeared at the injection site. This is accompanied by redness, itchiness, and pain.

Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-Present Inject Site Soreness - 5 PM - 02/26/2021 Increase in Abdominal pain - 5 PM - 02/26/2021-present 101.2 Fever - 5 PM - 02/26/2021-02/27/2021. Lowered to 100.1 2/28/2021-present. Muscle aches - 6 PM - 02/26/2021 - lasted through the night only Dizziness - 10 PM - 02/26/2021-present Dry throat and mouth/unquenchable thirst - 10 PM - 02/26/2021-present Loss of voice (no sore throat) - 11 PM - 02/26/2021 Heart racing - 02/27/2021 since waking up - lasted about 30 hours Rash on left shoulder and arms. Itchy. 2/28/2021 - 9 AM to present

Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus causing loss Of blood flow to my hand and feeling

Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.

Pt states "I received my second covid vaccine at 3:30pm on 02/25/2021 and I started feeling really tired about 20 minutes later at approx. 3:50pm. I started getting really hot and sweaty. I had my temperature taken and it was fine 97.6. My chest turned really red, and I got really sleepy. By the time I got home at 5:00pm my temperature was at 99.0. I had a headache, muscle aches all over, and chills. That evening my temp was 99.6. I took 500mg Tylenol around the clock. It hurt to move and to get up to go to the bathroom. The body aches have went away but I am still feeling really fatigued today 03/02/2021. I don't feel 100%."

UNKNOWN COVID VACCINE BRAND; chief complaint of generalized body aches and increased heart rate onset today. Per the patient, symptoms are beginning in the context of having received the second dose of her COVID-19 vaccine. Patient reports similar symptoms after her initial dose; however, these resolved shortly after. Patient states that she went to an urgent care for her symptoms but was sent to the ED for further evaluation. Back pain is describes as achy and constant.This initially began at the injection site but began to involve the back. Patient reports taking Tylenol around 1000 today without improvement in symptoms. Administered acetaminophen, magnesium (hypomagnesemia), 1 L NS bolus

My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.

Light-headness within forty five minutes - a little dizzy; tiredness; nauseous; swelling on injection site - it was a little worse then on the first dose (I forgot to mention that I had swelling on the injection site after the first dose, too). These symptoms lasted for about two weeks. I took Benadryl to help with the symptoms - it helped the symptoms to let me to sleep. A week and a half before I took the second COVID vaccine, I had a TB test done. Exhaustion is still there and I still have nausea. Dizziness has been gone since second week of the 2nd dose of vaccine. Swelling on the injection site is gone. I had a doctor visit - Video visit with clinic and the dr recommended bedrest - February 11th or 12th - no meds given. I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.

Occasional soreness at injection site. Continued experience of tiredness, sleeping at 7 or 8 PM, when normally sleeping at 12 or 1 AM.

Soreness at injection site throughout day. Experiencing unusual tiredness, sleeping at 7 or 8 PM, but normal sleep time is 12 or 1 AM.

First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and breasts, itchy eyes and nose, sneezing

Pain in left arm near injection sight; pain when pressed or when arm raised and using the muscles in that area. Slight tickle in back of throat.

Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+ hours as well.

Approximately 90 minutes after vaccination, patient reports noticing 1 hive on left cheek, then within another hour developed hives on face, neck, back, and progressed to chest. Then patient reports tingling and itchiness on lips and in an around her mouth. At this point the patient took benadyl (diphenhydramine) OTC 25mg tablets. Hives resolved post-benadyl within 60 minutes and continued itchiness on skin until next morning. All symptoms/hives/itchiness resolved by next morning.

First, I had moderate pain in my right arm and near the injection site. After the first dose, my right arm and hand became numb with loss of feeling or touch. This lasted for most of the evening, about 12 hours after vaccination. The injection site and the muscle were in a lot of pain, which climbed up into my neck muscle. I did not have any fever or chills. For the past several days, I have become fatigued very easily. Lastly, my lower abdominal area has become sore with discomfort. I have never experienced this before, and I am not currently menstruating either. Tylenol makes it better, and resting on my back and excess movement makes it worse.

I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little bit on my face and arms. Then it went away. I got home around six pm. I had to go to the bathroom and first go was a mix of diarrhea and solid stools. Then as soon as I left the bathroom, I had to go back. It was fully blown diarrhea. Then I kid you not, my period came on at the same time. It is usually unpredictable but I wanted to add it just in case. And my arm became really really sore around 8pm and last night I could barely move it from the pain, or lift it. This morning it is still sore...and hurts to put pressure on .

Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near point of injection on left arm only.

Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vaccine tent at 1800 stating she had a "splitting headache, was cold, clammy and nauseated." Vital signs SPO2 99% HR 72 and regular, Blood pressure 148/98, skin dry, hands cool, at this time denying nausea, still with complaints of headache. At 1830 HR 75 regular heart rate remains regular, SPOS 99%, denies any airway issues, declined water or crackers, wanted to go home.

Reaction: Red dots on bilateral arms, no itchiness or warmness Outcomes: Observed for an additional 15 minutes, gave Benadryl 25 mg PO x1. Decreased redness after 5 min of Benadryl

I was vaccinated with the first dose of the Pfizer vaccine on 3/3/21. I started experiencing itching on my chest and back on 3/4/21. The itching sensation increased and I broke out in hives on the evening of 3/5/21. I took an antihistamine and the hives subsided. The itching and hives started near the vaccine injection site on my left arm and spread across my chest, back, and to my right arm.

?Dizziness almost immediately and still ongoing ?Tongue tingling about 30 minutes after shot and subsiding around 1:51 ?Pain at injection site ?overall out of it ?off? feeling ?Feeling of panic ?Fatigue ?Chest feeling heavy at about 12pm on day of vaccine lasting about an hour

Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant muscle spasms.

Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and itchy skin on entire torso. No hives noted. No other symptoms. Actions Taken: Vitals taken at 1722 as follows: 135/82, HR 86, Respirations 14. O2 sats on RA 95%. No c/o shortness of breath, throat closing, itchy throat, SOB or stridor. After 15 minutes, Pt feels the same and no changes for the worse. Vitals at 1738 as follows 119/68, HR 85. O2 sat 96% on RA. Pt requests to head home and will take Benadryl upon arrival. Disposition: PT d/c to home per pt request @ 1820

Stark dark red rash on lower left breast and abdomen. Started 03/14/21 in the middle of the night when I was sleeping. In the morning it was still there so I took a benadryl with no relief. It became more inflamed, started itching and came with discomfort. Began feeling feverish and dizzy. Saw an NP 03/15/21 around 2:00pm and was given steroid cream to treat what she thought was an allergy. Steroid cream and cold compresses were used over the course of the next two days with no relief. Rash seemed to get bigger and darker. The rash is 4-5 irregular, textured and raised clusters about 1-2 cm in size, with mildly erythematous areas surrounding them. Saw an MD 03/17/21 around 1:30pm, believes it's a vascular response to the vaccine as the color of the rash doesn't fade when pressed on. Advises getting a biopsy if issue does not resolve or improve after 1 week. He also advised holding off on the second dose until further information is obtained

Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.

Client came to charge nurse complaining of red rash appearing on arms and chest 15 minutes after vaccine administration. Patient was not in any visible distress. Vitals taken, blood pressure 148/111, HR 103, O2 97%, RR 20. Patient does not complain of any pain or discomfort, trouble breathing or itchiness. Benadryl 25 mg PO administered for red rash on arms and chest. Patient rested, upright in chair for additional 15 minutes. No new complaints brought up by patient. Vitals at 5:09 pm 134/90, 98 pulse, 96% O2, 98.5 temp, RR 18. Lung sounds clear. Patient able to tolerate walking and was accompanied by partner. Patient left site without incident.

Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, followed by cold sores

I had minor hives on my neck and chest. I felt dizzy, foggy, and very fatigued for the rest of the day after getting this vaccine.

Exhaustion Fatigue Weakness Dizziness Itchiness of injection site, face, arms Runny nose Headache

Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/18/2021. Patient has a medical history of Ehlers-Danlos Syndrome, Mast Cell Activation Syndrome, POTS (Postural Orthostatic Tachycardic Syndrome). Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1431. The patient was given an observation time of 30 minutes with EMT. At 1505, the patient reported experiencing tingling in the back of her throat. The patient presented with patchy erythema on chest and neck. The patient was brought into the exam room at 1510 and proceeded to lay down on exam table. At this time, the patient's vitals were taken by RN and found to be within normal limits (BP 115/90, HR 88 BPM, RR 15/min). The patient denied difficulty breathing. She reported feeling minor dizziness and minor itching of neck and arms. The patient's vitals were reassessed as the Lead RN drew up 50 mg/1 mL of IM Benadryl. The patient's vitals at 1518 were: BP 120/85, HR 80 BPM, RR 16/min. The patient remained A&Ox4. The patient was given 50mg of IM Benadryl at 1520 in the left anterolateral region. At 1530, Patient's vitals were: BP 117/80, HR 73 BPM, RR 12/min. At this time, the patient verbalized relief of itching in neck and arms. Upon assessment, the patient's erythema on neck and chest had resolved. At 1537, the patient sat up with her feet dangling below her, her vitals were as follows: BP 132/98, HR 73 BPM, RR 13/min. The patient reported "feeling better" and requested to use the restroom. An RN followed the patient to the restroom. Patient's gait was steady and she denied any dizziness or lightheadedness. Lead nurse educated patient on side effects of Benadryl, including drowsiness. At 1544, the patient requested to drive herself home. She was escorted to her car by lead RN. Patient drove herself home AMA at 1547.

pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contactable consumer reporting for herself. A 27-year-old non-pregnant female patient received her first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: 9266, via an unspecified route of administration, administered in left arm on 25Jan2021 at 08:45 (at the age of 27 years old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date, blood triglycerides increased from an unknown date, and drug allergy to cephalosporins from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Six hours after vaccine administration, the patient experienced pain at injection site/ left arm on 25Jan2021, and pain when raising arm on 25Jan2021. The patient did not receive treatment for the events. The outcome of the events pain at injection site/ left arm, and pain when raising arm was recovered on 26Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Patient experienced facial rash with dose 1 that was relieved with Benadryl 50mg PO. Patient experienced spreading body rash with difficulty breathing experienced as persistent cough with dose 2. Symptoms were not relieved with Benadryl 50mg PO and continued to worsen. Patient was administered 0.3mg epinephrine IM (as EpiPen), 911 was alerted, and an ambulance took patient to hospital.

Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Also experienced severe pain at the injection site, that worsened over the evening. All symptoms continued through the evening. Also experienced night sweats. The following morning, headache and mild chills were present, but other symptoms had abated. Had minor brain fog. Those symptoms resolved over the course of the day. All symptoms, except night sweats, have cleared up. Night sweats are ongoing.

Red/irritated skin, rash, hives, and itchy skin along both legs (front and back) - I took one Benadryl pill and put anti-itch cream on both of my legs. The rash/hives were gone by morning.

03/23/21 -sore arm -body aches -headaches -weakness -fatigue -chills 7:00pm -102.5 fever -rash surrounding injection site -slight swollen armpit -cold sweats -headaches -body aches 03/24/21 -101 fever -body aches -chills -cold sweats

Fever of 104.1 lasting for 24 hours, Brady aches, chills, swelling the size of a baseball and redness at injection site

PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW MINUTES LATER SHE DEVELOPED SHORTNESS OF BREATH AND SENSATION OF HER THROAT CLOSING. SHE WAS GIVEN BENADRYL 50 MG IM AND EPI 0.3 MG IM. THEN PARAMEDICS TRANSFERRED HER TO THE EMERGENCY ROOM.

Patient complained of itching and hives 5 minutes post vaccination. Benadryl 50 mg IM @RD given at 1:32pm. Patient felt dizzy. Laid down with feet up. Patient complained of difficulty swallowing and breathing at 1:47pm. Epipen administered on left outer thigh intramuscularly. 911 called. Transferred to Hospital via ambulance at 2:01pm. Vital signs: 1:25pm BP 110/75 O2 sat 98%, 1:30pm BP 110/80 HR 86bpm; 1:54pm BP 120/95 , HR 137 bpm, O2 sat 98%; 1:57pm HR 124 bpm. Lungs clear to auscultation. Called patient at 6:12pm for follow-up. Patient is still in the hospital for observation. She received treatment and under observation.

Soreness at injection site started 3 hours later. Fever over 100F, aching muscles, nausea, fatigue, headache all started at 7am the next day.

fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 25Jan2021 02:00 PM at single dose in right arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history included Anxiety/depression, high cholesterol. Patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as none. Concomitant medications the patient received within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL), loratadine, melatonin, norethisterone (ERRIN birth control). It was reported as in addition to the side effects of fatigue, headache, chills, and muscle aches, I experienced lymph node swelling lasting over a week as well as injection site pain which is still occurring and all on 26Jan2021. No treatment received for the adverse events. Since the vaccination, the patient had been tested for COVID-19. Patient underwent labs and procedure included PCR (Polymerase chain reaction): Negative (Nasal Swab) on 26Jan2021. The outcome of event injection site pain was not recovered, while for all other events was unknown. No follow-up attempts are possible. No further information is expected.

headache; itches at the injection site; felt a little nauseous; This is a spontaneous report from a contactable Other HCP. A 27-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EJ1686), ), intramuscularly on Left arm on 20Jan2021 13:30 at single dose for covid-19 immunization. Other medical history includes Eczema, hypoglycemic, anemic. Known allergies includes Rondec. I had a baby. I had been weening from breastfeeding in January. As a result I start my menstrual cycle around the same day as I got my first shot. I sort of had a headache before the shot and definitely had one later that day and the next after the shot. I also felt a little nauseous the next day after receiving the shot. I also started my menstrual cycle again 2 weeks later (around February 8) which would be 2 weeks early. I've been on a birth control pill for 6 months and before having a child, would never had irregular periods. My left arm itches at the injection site for maybe 3 or 4 days. Adverse events was start date on 21Jan2021. And did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Recovered". Information on the batch number has been requested.

I developed very itchy bumps all over my body a few days after both the first and the second shot. The bumps were much worse after the second shot and continued to linger for over a month (bumps would fade and new ones would develop. Finally I took benedryl three nights in a row and that seemed to knock them back. I've done everything I can to rule out some sort of bug. The person with whom I share a bed has not been developing these bumps. They do not resemble bed bug bites. The closest resemblance is to mosquito bites, but there are no mosquitos in this area this time of year.

soreness of the injection arm; This is a spontaneous report from a non-contactable reporter. A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 in the left arm on 14Feb2021 (Batch/Lot number EN6201) as a SINGE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient did not do a test Covid post vaccination. The patient did not receive any treatment. Patient did not receive any other vaccine in four weeks. On 14Feb2021 after the first dose of the vaccine, the patient experienced soreness of the injection arm. Outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

3 Hives on neck and 6 hives on right arm.; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 12Feb2021 (at the age of 27-year-old), as a single dose in left arm for COVID-19 immunisation at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. On 13Feb2021 at 12:00, the patient experienced 3 hives on neck and 6 hives on right arm. There was no treatment received for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was recovering. Follow-up (23Feb2021): This follow-up is being submitted to notify that the adverse event occurred date and PRD was 13Feb2021. Information on the lot/batch number has been requested.

Hives; This is a spontaneous report from a contactable Other Health Professional (patient). A 27-Year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EL3247) via unspecified route of administration at arm left on 27Jan2021 at 09:00 AM as single dose for COVID-19 immunization. Medical history included allergies to sulfa antibiotics. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was not reported. Previously patient received first dose of BNT162B2 for COVID-19 immunization. On an unknown date, patient experienced hives. No COVID prior vaccination. Patient has not tested COVID-19 post vaccination. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITATIONS AND WAS JITTERY. SHE DEVELOPED RASH ON CHEST. 911 WAS CALLED AND EMS CAME AND TOOK PATIENT AWAY FOR OBSERVATION

Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on affected side. No treatment appears to improve conditions.

she gave it down towards her knee on her leg; injection was very painful/some burning during the injection; injected the area swelled up as she gave it and became red; injected the area swelled up as she gave it and became red; had a flare for the past couple of days/pretty bad flare/ put her into a flare/ Feeling really bad; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen , license party for etanercept (ENBREL). This non-serious solicited report was reported to Amgen on 05Apr2021 by a consumer from a commercial program and involves a 27 year old female patient who gave it down towards her knee on her leg (PT: product administered at inappropriate site), injection was very painful (PT: injection site pain), injected the area swelled up as she gave it and became red (PT: injection site swelling and PT: injection site erythema) while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on 04Apr2021. On 04Apr2021 last night, the patient took her first injection of Enbrel last night and when she injected the area swelled up as she gave it and became red. The patient reported injection was very painful and she recounted that she gave it down towards her knee on her leg. On 05Apr2021 same day of this report, the patient reported it was sore but no longer red. The patient was referred to HCP and arranged for an in home patient training for next injection. No treatment information was received. The outcome of the event injection site pain was reported as not recovered/not resolved. The outcome of the event injection site erythema was reported as recovered/resolved. The outcome of the events product administered at inappropriate site, injection site swelling were reported as unknown. The event injection site erythema was resolved on 05Apr2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain, injection site swelling and injection site erythema. The causal relationship between the events injection site pain, injection site swelling, injection site erythema, product administered at inappropriate site and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Causality Assessment for the events Pain during injection, Injection site redness, Injection site swelling, per Company (Amgen): related. Causality Assessment for the event Product administered at inappropriate site, per Company (Amgen): Not related. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 12/APR/2021 AND 20/APR/2021: This case was upgraded to serious case. In this follow up, it was reported that the patient had a flare for the past couple of days/pretty bad flare [PT: rheumatoid arthritis], some burning during the injection [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. It was previously reported that the patient first injected close to her knee and had a bad injection experience with immediate pain and swelling at the site. On unknown date in APR/2021, the patient stated that for the past couple of days she had a flare especially in her hands. On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain. On 16/APR/2021 (Friday of last week), the patient had a pretty bad flare that subsided on the weekend prior to her last injection. On 19/APR/2021, the patient injected in her thigh and she had some burning during the injection that lasted for about a minute afterwards. The outcome of the events rheumatoid arthritis and injection site pain were reported as recovered/resolved. The event injection site pain was resolved on 19/APR/2021. The event rheumatoid arthritis was resolved on an unknown date in APR/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis, Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Comment: This individual report does not change the safety profile of the product. Amgen Causality Assessment: Rheumatoid arthritis flare up, Product administered at inappropriate site assesses as unrelated while Injection site redness, Injection site swelling, Pain during injection assessed as related to etanercept. Follow-up (26Apr2021): The following clarification was received from Amgen to clarify the route of administration of Enbrel, included: The event reported was Product administered at inappropriate site "gave it down towards her knee on her leg [PT: product administered at inappropriate site" & "when she injected the area swelled up as she gave it and became red." Following the initial dose that was administered inappropriately, "On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain" The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Follow-up (27Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 27/APR/2021: The outcome of the previously reported event rheumatoid arthritis was updated to recovering/resolving. Action taken with Enbrel, Single Dose Prefilled Autoinjector for the previously reported event rheumatoid arthritis was updated to not applicable. In this follow up it was reported that the patient experienced a flare/ feeling really bad [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included COVID-19 (corona virus disease-2019) vaccine. On 25/APR/2021, Sunday, the patient received her second dose of COVID (corona virus disease) vaccine. So, the patient skipped a dose of Enbrel therapy. Then on 26/APR/2021, yesterday of this report, the patient felt really bad. She thought the vaccine put her into a flare. She was doing a little better today. She would restart Enbrel later today and switched her injection day to Tuesday. She also mentioned that this time, she didn't have a flare at the end of the week, as she had with her prior dose. So, she thought that without the COVID vaccine, she would had been fine. The outcome of the event rheumatoid arthritis was reported as recovering/resolving. No follow-up attempts are possible. No further information is expected. Amgen comment: This individual report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events with the suspect products etanercept and BNT162B2 (reported as "COVID vaccine") was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen's Causality Assessment: The events Pain during injection, Injection site redness, Injection site swelling were related to etanercept. The events Rheumatoid arthritis flare up, Product administered at inappropriate site were unrelated to etanercept.; Sender's Comments: The reported events of injection site pain, injection site swelling and injection site erythema were assessed as possibly related to etanercept based on temporal association and known drug safety profile. Reported event rheumatoid arthritis flare is an intercurrent medical conditions and is unlikely related to Enbrel. Pfizer comment: Confirmed the Amgen assessment for Enbrel. The reported events were assessed as not related to BNT162B2. The events preceded, most of them already recovered, at the time of vaccine injection.

From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).

tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.

31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injection site 31 Dec 1700 fever 102.1, injection site welt hard, painful, hot with 3 inch diameter, severe body aches and chills. Alternating Tylenol and Motrin begins fever lowers to 99 01Jan severe body aches and chills 01Jan 1130 fever of 101.1 while continuing alternating Tylenol and Motrin administration from previous day. 02Jan no fever, mild body aches, minor swelling and tenderness of injection site.

S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient alert and oriented, airway patent. BP 129/88 HR 74 O2 98% 1617 Repeat O2 sat 98% HR 59. Patient c/o persistent tongue swelling.   A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation.

36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the areas where I have HA fillers - lips and tear troughs. Both Restylane products. Ended up going to the ER at 2 AM and receiving angioedema/anaphylaxis protocol. IV benedryl, famotidine, and solumedrol. Was put on prednisone and hydroxyzine for at home care for the next 3 days after event. Swelling went down by the next afternoon.

Employee had hives the day following vaccine, went to urgent care received prednisone 50 mg with daily taper, hives have continued to spread daily since. No angioedema or airway issues.

Patient reported to me that she developed a rash to her extremities the evening of vaccination. She proceeded to take benadryl. Patient reported taking benadryl repeatedly Tuesday, Wednesday, Thursday, Friday and by Saturday morning she had to go to the ER to get some steroids. Patient stated that it was a hive reaction.

Really strong left arm pain around injection site. Not able to extend or retract my arm for the day after injection. Was really painful, couldn't sleep or apply pressure to arm, also at one point I had an extremely sharp/shooting pain that was in my left arm/neck. Currently 5 months pregnant, due June 7th 2021

She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.

About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. This lasted throughout the day and required 50mg of Benadryl before symptoms finally subsided around 9pm that night.

About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my face. I got in my car and realized it's not going away. I need advice on what to take for it to go away. I noticed a itchy throat. Not sure if it's something that's due to the vaccine.

Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.

Exactly a week later, I noticed I had a 2 inch lump underneath my chin where my lymph node, it was tender to the touch. on 1/5th, I can still feel the lump, but is not longer tender to the touch. I also developed blisters ( almost like herpes like) on the R side of my nose and on the inside of my nose. I never had blisters in my life, or herpes like blisters on my face. Now on 1/5/21, the blisters are starting to dry, but are still there. I as ask to contact you guys to see if I can get my second dose.

Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM

Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; This is a spontaneous report from a contactable other HCP (patient herself). This 28-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route of administration, on 19Dec2020 at 15:00 at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included sinus tachycardia and obstructive sleep apnea. Patient's Body mass index (BMI) is more than 35. No known allergies. Relevant concomitant medications included ibuprofen. The patient was vaccinated at Clinic, age at vaccination was 28-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 28Dec2020, at 12:30, the patient developed tenderness, redness, and swollen at injection site, approximately 2 inches by 1 inch in size. The patient was not treated for the events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVID per employee health policy on 12/31 - negative. Rash began 2 days after vaccination. was seen at Urgent care on 1/2/21, given prednisone. Rash worsened, fever broke. seen again 1/3/21 - given kenalog shot. tested for COVID-19 (negative). Rash continues to spread, headache improved but not resolved.

Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.

swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area; redness; to the arm/deltoid area; inflammation; to the arm/deltoid area; swelling/cellulitis in her left arm/swelling; to the arm/deltoid area; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at left deltoid on 16Dec2020 16:45 at single dose for Covid-19 immunization at a hospital facility and not in a military facility. Medical history included ongoing acne. Concomitant medications included ongoing spironolactone for acne. The patient did not receive any other vaccines the day or 4 weeks prior Covid-19 vaccine. The patient informed that after 8 days of getting Covid vaccine she has swelling/cellulitis in her left arm. The patient got the COVID-19 vaccine and had kind of a delayed reaction. She got the vaccine on 16Dec2020 16:45 pm at her workplace. The patient informed that she had no reaction right after the vaccine. On 24Dec2020, the patient experienced redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area. The patient got antibiotics and it has improved. The reporter informed that the events required visit to physician office. The outcome of the events swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area was recovering. The patient was queried regarding seriousness of the events and the patient stated "it could have potentially dangerous." The patient wanted to know if she should get second dose of the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site cellulitis, vaccination site erythema, vaccination site inflammation and vaccination site swelling cannot be excluded.

swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. Four hrs post injection c/o general body ache, slight headache, fever 99.7. Denies any respiratory, ocular, or GI symptoms. Note - injection lot # not available.

Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.

Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be red faced along with redness in her throat and chest. Pt given Benadryl 25 mg liquid po at 0925 am and coaching for slowed breathing and symptoms recovery. She reported feeling better gradually and with in 15 minutes pt felt much better she declined ER transport

had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.

2 hours after receiving the vaccine, patient noticed blochiness on chest and fever. Last 2 hours and the went away.

Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Dec2020, the patient experienced chills, subjective fevers less than 100, fatigue, and soreness at injection site 24 hours. The clinical outcome of chills, subjective fevers less than 100, fatigue, was recovered on an unspecified date. The clinical outcome of soreness at injection site 24 hours was recovered on 17Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.

First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd COVID-19 Pfizer vaccine. 27 hours following administration of the vaccine in addition to body aches and chills, I then experienced headaches, fever of 101.8, and fatigue.

Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; This is a spontaneous report from a contactable other hcp reporting for herself. This 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose on 15Dec2020 14:00 (Lot # EK5730) in the left arm and the second dose on 04Jan2021 12:45 (Lot # EL1284) in the right arm, both via an unspecified route of administration at single dose for Covid-19 immunisation. Medical history included asthma and allergies to Penicillin and Oxycodone. Concomitant medication included omalizumab (XOLAIR), salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 04Jan2021 23:00, the patient experienced injection site soreness, fatigue/chills (day). Bad diarrhea at night. No treatment was performed. The outcome of the events was recovered. The patient underwent lab tests and procedures which included Nasal Swab, Covid test on 28Dec2020 was negative. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.

Patient began experiencing itching at the injection site and then all over her body. She started feeling very warm and developing hives. She was given diphenhydramine 25mg by mouth. 911 was called and she was taken to the ER. The ambulance arrived about 5 minutes after 911 was called.

Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tongue and inside of the mouth was itchy, rash on upper body and swollen inflamed painful lips.

Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began 12 hours after injection. Fever spiked up to 104.1F 16 hours after vaccination. Took Tylenol at hour 16 to help bring fever down. Temperature now 100F and it has been 18 hours since vaccination.

Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection. Course to come yet unknown.

Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot

At about 11pm the night of vaccine (1/6/2021) my arm began to feel sore at injection site. Then 5 am (1/7/2021) my head began to hurt. I then had a fever of 100.7 beginning at 6:45 am (1/7/2021). Throughout the day I had chills and my temp fluctuated between 99.6 and 100.4.

Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, muscle and joint aches, malaise, fatigue, and pain at injection site

Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiving the vaccine. 7x8cm area of erythema, warmth and induration at injection site.

Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fields (confirmed by MD.) Developed hives- Albuterol, Benadryl and epinephrine administered @ 700pm. EMS called and transported to Hospital.

Developed a red rash to injection site that soon spread across upper back and neck. No shortness of breath. No difficulty breathing. No loss of consciousness. 10:25 pm - Epi pen 0.3 mg IM given x 1 . Benadryl 50 mg x 1 dose given. EMS called and arrived within 4 minutes. Patient transported to local ER for further evaluation and treatment.

Mild rash and itching around injection site; itching around injection site (multiple small red bumps); itching around injection site (multiple small red bumps); This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 14:45 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included celiac disease, Sjogren's syndrome, connective tissue autoimmune disease, allergies to Gluten. Concomitant medication included cetirizine, citalopram, curcuma longa (TURMERIC), ergocalciferol (VIT D), ethinylestradiol, norethisterone acetate (MICROGESTIN), fish oil, hydroxychloroquine, pantoprazole, simethicone, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild rash and itching around injection site (multiple small red bumps) on 31Dec2020, all events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number has been requested.

I noticed on January 12 that my left arm where I received the shot my bones were aching and my joints (my shoulder, my elbow, my forearm bones, and all my hand joints) were aching and my hand was slightly swollen. My coworker reported aching joints two days after she received the vaccine. So I?m not sure if my aching joints are related to the vaccine but I?m suspicious they are.

My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.

at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, headache, and felt febrile. I took my temperature twice in the absence of antipyretics and did not have a fever (98.7 and 98.2) but my skin felt hot and painful as it does when I have had a fever in the past. By about 5:00 or around 24 hours post vaccination, all symptoms resolved aside from fatigue and headache, but the headache was less than it was before. I experienced those symptoms for the rest of the evening and woke up this morning feeling completely normal.

dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills, and headache. 1/12/2021 8:00am - severe body aches, fever up to 101.0 degrees Fahrenheit after takingTylenol and chills. 1/12/2021 6:00pm - fever 100.6 degrees Fahrenheit after taking Tylenol, shortness of breath, and deep dry cough. 1/13/2021 11:00am -shortness of breath, deep dry cough worsening with tachycardia. Went to urgent care diagnosed with upper respiratory infection due to second covid vaccine reaction prescribed prednisone.

About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.

Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient). A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021. It is unknown if the patient has been tested for COVID-19 since the second vaccination.

Developed a rash around my neck and swollen eyes (thought to be poison ivy) on 1/3/2021. Since that time, the rash has spread to my back, abdomen, chest, neck, ears. It appears to be urticaria and is extremely itchy. I completed a steroid taper early on and the rash is no loner affecting my face. I am taking daily antihistamines and using hydrocortisone cream for the itching. The rash continues to spread and is made worse with scratching. I am unsure if this is related to the vaccine, but this has never happened before and I have no known allergies. I got the second vaccine on 1/8/2021 (at the time the rash was improving and I thought it to be poison ivy).

Hives on left arm several inches from vaccination site and one hive present on left thigh - patient unable to wait the 15 minutes, sx occurred 5 minutes post vaccination. Itching occurring on left arm and thigh and chest. No respiratory or cardiac symptoms. Self-administered Claritin after sx occurred.

I received the second dose of the Pfizer vaccine on 1/8/2021. The following day I had mild hives on my neck and thigh creases, I attributed it from sweating, hives went away after taking Claritin. The evening of 1/11/2021 I had 1 glass of wine and subsequently broke out into hives all over my chest and neck, took Benadryl that night. In the morning of 1/12/2021 the hives had worsened. I started Prednisone 40mg, Claritin, Pepcid 20mg in the AM and Prednisone 20mg, Benadryl, Pepcid 20mg at night. The following day the hives had mostly resolved and I only took the OTC medications. In the afternoon of 1/13/2021 I rode my stationary bike. After the ride I had broke into hives again on my chest and neck and where my headband sat. I then took Prednisone 40mg, Benadryl 25mg, Pepcid 20mg. Hives have mostly resolved today 1/14/2021, still have the sensation of itchiness. Never had throat closing or shortness of breath.

Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, coughing, tingling in the tongue. Itchiness progressed down arms, as did hives. EMS arrived and administered 0.3 mg Epi IM and IV Benadryl. Vitals obtained.

same day: pain at injection site next day: headache, fatigue, paint at injection site, muscle aches 2 days after: no symptoms

Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.

Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and nonpruritic, erythematous rash chest to thighs. Woke that night with tachycardia to 220's. Tachycardia of varying degree and severe diaphoresis was constant through the next 72 hours. Did not seek care. Since then, for 3 weeks she has had multiple runs of SVT. Last one was Saturday 1/9 - went to ER, episode recorded. Given rx of xanax which did not resolve her tachycardia. Established care with me 1/14/2021 and noted to have 3/6 systolic murmur. Patient (who is a PA) states it is significantly louder than it was prior to vaccination. Given rx of prn propranolol for home, outcome pending

Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches

Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches

Within 10 mins I had Hives on my chest and back. My face and ears started turning bright red and swelled a little. Then for a week I was itchy. I took Benadryl and hour after the incident. The EMS monitored me while It was happening and since I was still breathing ok I decided to leave and get Benadryl since they didn't have any.

Almost 24 hours after receiving I got really itchy all over my body and had hives on my inner thighs.

Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.

Recieved dose #1 of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site.; This is a spontaneous report from a non-contactable nurse. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK798), intramuscular in the right arm on 18Dec2020 13:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ergocalciferol (VIT D), ethinylestradiol, norethisterone (NORTREL [ETHINYLESTRADIOL;NORETHISTERONE]). The patient previously took and had allergies with Phenergan. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 post vaccination. The patient received first dose of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site on an unspecified date with outcome of recovering. The event was reported as non-serious. No treatment received for the event. No follow up attempts are possible. No further information is expected.

difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

localized pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at a single dose to prevent COVID-19. The patient had no medical history. There were no concomitant medications. The patient got the second dose of the Covid-19 vaccine on Friday, 08Jan2021 (lot number: EK9231, expiration date: Apr2021). She didn't have a fever or chills, but she had localized pain which she also had with the first dose. She still has pain in her armpit, to the touch and when she moves it, but there is no swelling, lumps or bumps. The pain has decreased; it's not as bad as it was when she first noticed it. The localized pain at the injection site was worse with the first injection in Dec2020; she just did not have the underarm pain and she didn't have any pain until the day after she got the first dose. She got the 2nd dose at 5:30pm, and had pain at around 8pm or 9pm that night. The following day was the height of the pain for the second dose, and it has been decreasing since then. She got both doses in her left arm. Outcome of the event was unknown.

1/14/21 severe chills , fever of 101.9, treated with ibuprofen throughout entire day, sweats, headache, fatigue, body aches, nausea, soreness at injection site 1/15/21 headache, fatigue, body aches, nausea, dizziness, soreness at injection site, numbness and soreness of right 5th metacarpal; took ibuprofen for headache 1/16/21 headache, dizziness, fatigue, nausea, body aches, numbness and soreness of right 5th metacarpal 1/17/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal; took Tylenol for headache 1/18/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal 1/19/21 tiredness, nausea, numbness of right 5th metacarpal

Woke up the morning after the vaccine with dizziness, nauseous, dull headache, sensitivity to light/sun. Feeling some pain at injection site and is similar to the first vaccine in the series. Has not yet taken any meds to alleviate the reactions; but will take Advil. After the first injection, patient mainly had injection site pain, but no other adverse reactions. Has not contacted doctor regarding reaction, but is not going in to work.

Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)

Red bumpy, itchy rash developed a few hours after receiving vaccine (vaccine received at 1100, itching, redness, and rash began around 1330), localized to injection site, over course of 24 hours spread to face, entire trunk, and upper thighs. Notified physician, who order medrol-dose pack. Treatment started at 2130on Saturday, 1/16/21. Symptoms began to decrease within 3 hours, subsided within 48 hours.

Shingles Virus- Rash began Friday 1/15/21 (about 48 hours after vaccination) on back left side, rash spread to underneath left breast

I just wanted to report an incident that occurred after receieving the first dose of the covid vaccine. It was not one of the possible reaction from covid vaccine but rather administrator error in injecting the vaccine. The symptoms appeared about 3 hours after receiving the vaccine, now have numbness, tingling, pain and burning sensation on my left pam in the arm of given vaccine. Obviously, the person giving the vaccine, hit the nerve.

Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after vaccine given. Patient also noticed stiffness in neck, feeling of pins and needles and some skin burning. Additionally endorses feeling a dry mouth sensation.

Two to three hours after receiving the second dose of COVID-19 Pfizer-BioNTech vaccine, the patient began to have generalized rash erythematosus with hives. The patient was transferred to the Emergency Room and following the evaluation the patients was treated with Solu-medrol 125 mg IV single dose and Benadryl 25 mg IV. single dose.

Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen

Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.

sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EK9231) , via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 16Dec2020 (lot no: EH9899) administered on left arm. Patient was not pregnant. The patient has no COVID prior vaccination. On 07Jan2021, patient stated "I had a sore arm at the injection site. I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2- 100.4 for majority of day and decreased to 99.6 that night. It only lasted the day after being vaccinated" The patient recovered on unspecified date from all of the events. The patient has not tested COVID on post vaccination. No follow-up attempts are possible. No further information is expected.

I had a fever in the middle of the night, but no pain at the injection site. On Monday, January 25 my arm and part of my back felt like they were burning/itching and were sensitive to clothing and clothing tags. Not anything major or that i'm too concerned about, but wanted to know if any others have experienced this as well. My skin isn't red and there's no rash- it is only hypersensitive to touch. I don't have any food allergies or any allergies to medicines. I've never had adverse reactions from a vaccination before and my skin is typically not sensitive to anything.

fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; Enlarged axillary lymph node/Became red and warm at day 10 in same arm; This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine, lot EH9889), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included allergy to latex and COVID prior vaccination: No. No other vaccine in four weeks. Concomitant medication included unspecified oral contraceptive. The patient experienced enlarged axillary lymph node that appeared 8 days after vaccine administration (05Jan2021). It became red and warm at day 10 (07Jan2021) in same arm as vaccine was administered in. Required Keflex 500 mg oral antibiotics for infection. No Covid tested post vaccination. The outcome of events was recovering.

My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .

Tenderness at site Low grade fever; Tenderness at site Low grade fever; This is a spontaneous report from a non-contactable Nurse(patient). A 28-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown), via an unspecified route of administration at left arm on 12Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included hypothyroidism. No COVID prior vaccination, no COVID tested post vaccination, no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), ethinylestradiol, norgestimate (SPRINTEC). No other vaccine received in four weeks.The patient experienced tenderness at site low grade fever on 13Jan2021 04:00. Facility type vaccine was hospital. No treatment received. Outcome was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue

Injection site pain with 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3248, intramuscular on 22Dec2020 07:00 at a single dose on left arm for COVID-19 immunization. There were no medical history or concomitant medications. The patient is not pregnant and had no known allergies. The patient had no prior vaccination and not tested post vaccination. The patient experienced injection site pain with 1st dose. There was no treatment received. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Rash; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 07Jan2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included history of seafood allergy during the childhood and allergic reaction to shampoo, conditioner and skincares. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jan2021 (reported as around a week after the second shot), the patient experienced rash. The patient took an antihistamine as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.

Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fever; severe headache and chills -counted get warm - lasted about 48 hours. But my arm was really sore for another 2 days after all the other symptoms cleared. Treated with Tylenol around the clock throughout.

This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response. She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.

immediately developed a raised itchy welt to injection site that continues to get larger and is now painful

Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye pain when looking at light

Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and throat about 10 minutes post Covid-19 vaccine (Pfizer EL9261, exp. 5/1/21). History of vasovagal reactions. Also said numb tongue made her think of trouble swallowing. Given water, Benadryl 25mg PO, Zyrtec 10mg PO, and Famotadine 20mg PO and felt better. Heart: RRR without mrg Lungs: clear Skin: blotchy and slightly flushed in spots Throat clear No problems swallowing medications, also given Ginger Ale

6 hours after shot Injection site swollen and red and hot to the touch. Also very itchy and painful. Two days later lumps have formed in my neck and under my armpit. They are painful and movable. I am having an ultrasound in a few days on them.

After client received her COVID-19 Pfizer vaccination, client was sitting in the observation area of the vaccine clinic (as required after receiving the vaccination) and it was observed by the EMS person and Public Health Nurse that was there, that client was itching her forearms. Client had developed a red rash, starting on her arms and then her neck and chest (blotchy red). She complained of itching on her arms, neck and then her head. She reports she felt like she was "on a boat", feeling lightheaded. Client was taken to the emergency room where client reports she received IV Benadryl. Client reports that after being at the ER for 1.5 hours, her rash resolved and she no longer felt lightheaded. Reports no other symptoms after that.

I don't know when it formed, but on 1/31/21 I notice a white halo around the injection site on my left arm. There is no pain, it is very faint but clearly there.

Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; This is a spontaneous report from a contactable other healthcare professional reported for a female patient. A 28-year-old female patient receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), intramuscular (anatomical location: arm left) on 19Jan2021 at 13:00 at SINGLE DOSE for covid-19 immunization. Patient's medical history included birth control. Concomitant medications included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) as birth control, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone nasal spray, and probiotics. The patient previously took first dose of bnt162b2 (lot number: EH9899; expiration date not reported), intramuscular (anatomical location: left arm) on 29Dec2020 at 09:30 am for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. It was also reported that patient was not pregnant at the time of vaccination. On 20Jan2021 at 07:00, the patient experienced skin rash/redness at injection site and in axilla on side of injection. It was reported that no treatment was provided for the events. The events were assessed as non-serious. Outcome of the events was recovering.

elevated redness sort of like a rash around the injected area; rash came back in the injected area; it was itchy; my face was swollen and ears; my face was swollen and ears; hives on my face; skin was very dry; rash like; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 31Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for Covid-19 immunization. Medical history included tuberculosis (TB) when younger and took medication for it from an unknown date. The patient was allergic to penicillin and breaks out in hives and a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the vaccination, the patient experienced elevated redness sort of like a rash around the injected area for 2 days and then it went away, exactly a week later the rash came back in the injected area but did not spread and lasted another two days. On 14Jan2021 at 04:00 the patient experienced broke up in hives on face, face was swollen, and ears and it was itchy. The patient experienced skin was very dry and rash like but not itchy on an unknown date in Jan2021. Therapeutic measures were taken for the swelling face, ear swelling, hives and pruritis which included Benadryl for 2 days which helped the events go down. The clinical outcome of the event injection site erythema, swelling face, ear swelling, hives and pruritus was recovered; injection site rash, dry skin and rash were unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

A rash appeared two days after the 1st injection, mainly on stomach; This is a spontaneous report from a contactable nurse reporting for herself. A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140), via an unspecified route of administration on 30Dec2020 07:00 AM at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 28 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included allergies to eggs, shellfish, peanuts. Concomitant medication included desogestrel, ethinylestradiol (APRI). On 01Jan2021 the patient experienced a rash appeared two days after the 1st injection, mainly on stomach. The event was reported as non serious and resulted in Doctor or other healthcare professional office/clinic visit. Treatment for the event included steroid cream. The event had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.

FIrst dose was administered on 05Jan2021; Fever; Sore arm around injection site; swollen and sore lymph nodes: neck and arm of of injection; swollen and sore lymph nodes: neck and arm of of injection; Indigestion; This is a spontaneous report from a contactable 28-year-old female consumer reporting for herself A 28 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3300) on 22Jan2021 at 08:15 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included Shellfish allergy and allergy to doxicicline. The patient received first dose of vaccine on 05Jan2021 at 03:00 PM on right arm, lot_number=Ej1685. On 22Jan2021 at 18:00 the patient experienced fever, sore arm around injection site, swollen and sore lymph nodes: neck and arm of injection Indigestion (as reported). At the time of the reporting the patient had not yet recovered from reported events.

Rash (scaly spots appeared over the left upper extremity and back - this isn't an uncommon autoimmune response for this patient) Brain fog Word finding difficulties Suspected decreased seizure threshold - unclear if partial seizure was elicited Intense fatigue Increased sleep Treatment: monitored for 30 minutes status post vaccine injection without any notable concerns; routine observation and monitoring given seizure history Time course: Rash lasted for 1 week; Brain fog/word finding difficulties last fully for 10 days, then started to dissipate; Fatigue and increased sleep lasted 1 week

Soreness of injection site; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via an unspecified route of administration in the right arm on 19Jan2021 at 06:15 P.M. (at the age of 28-years-old) as a single dose, dose 1 for COVID-19 vaccination. The patient had an allergy to nickel. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were unknown. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 06:30 PM, the patient experienced soreness of injection site. The patient did not receive any treatment for the events. The clinical outcome of soreness of injection site was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

fatigue; slight headache; nausea; sore arm (left); swollen lymph nodes -left arm; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at arm left on 30Dec2020 at single dose for COVID-19 immunization. On 20Jan2021, the patient experienced fatigue, slight headache, nausea, sore arm (left) and swollen lymph nodes (left arm). The patient outcome of the events was unknown.

Hives; itching; shortness of breath; chest tightness; severe hip and low back pain; severe hip and low back pain; headache; concomitant medications included mercaptopurine; concomitant medications included mercaptopurine; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular at right arm on 19Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications included mercaptopurine, mirtazapine (REMERON), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC). The patient previously took ADDERALL, HUMIRA and REMICADE and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at right arm on 30Dec2020 at 15:45 at single dose for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced hives, itching, shortness of breath, chest tightness, severe hip and low back pain and headache. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine, EPI PEN, TORADOL, acetaminophen, DECADRON, DILAUDID. The patient outcome of the events was resolved with sequel.

I received the 1st dose of the Pfizer COVID vaccine on December 17th at 0640. I first started noticing some discoloration on the right side of my neck in a patch on January 1st. Over the course of the next 3 days the area became more red, dry, raised (but still maculopapular), and spread from the right side of my neck around the back of my neck to the left side and then the front. The area was mildly itchy. I had not had any new exposures including no new shampoos, soaps, clothes, sprays, sheets, detergent, etc. I have never had a rash that looked like this, nor have I ever had a rash on my neck. At it's fullest, the rash was a large patch of red, dry skin on my right with small maculopapular circles scattered on the rest of my neck. Around January 6-7th, when I got the second dose, the rash began to spread down my sides. That area was more itchy than my neck. The rash appearance was very consistent, as was the distribution with what I have seen of pityriasis rosea in my patients where you start with a Herald patch somewhere and then the rash spreads to other parts of the body. In January I had sought out an appointment through a virtual healthcare. they were hesitant to start steroids so as not to interfere with my immune response. I started over the counter hydrocortisone. In the few hours after I put it on the rash would be less itchy, less dry appearing and less red, but still noticeably pink, then would return. The rash has finally completely dissipated as of February 3rd morning, so it was present for a little more than a month.

In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over body aches, 99.9 and then arm pain at injection site nausea and diarrhea 01/14/2021 nausea and diarrhea disappeared on 01/14 or 01/15/2021. Nausea and diarrhea with first dose for two days.

red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs; This is a spontaneous report from a contactable nurse, reporting for herself. A 28-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 15Jan2021 at 11:00 (at the age of 28 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included crohn's disease from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ustekinumab (STELARA), sertraline, imipramine, colestipol, and B12, all from an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination, The vaccine was given at a Hospital. On 15Jan2021 at 13:30, the patient experienced red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Medrol dose pack. The clinical outcome of red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Hives, Benadryl and Allegra, itchy, red welts all over my body except for my back, hands, face, lower legs, and feet.

Usual tiredness & adverse effect on PRN medication. I take sumatriptan for onset of migraine attacks. Ever since I received the 1st dose on 1/22/21, when I take this medication, my face starts to itch & has a tingling sensation (pins & needles feeling). I have been taking this medication for 10yrs & not once have I ever had this kind of reaction. I am a little scared.

itching rash, tingling and warming sensation in arm radiating down within 15 min of shot. Pt has history of several allergic reactions to foods and medications. Stated that this felt like a similar reaction. Provided OTC Benadryl and patient stated that it resolved fairly quickly after initial dose, but had to continue w/ Benadryl for 2 days afterwards otherwise rash would reemerge.

Developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back.; They itch when touch; Patient developed rash/They are raised, erythematous spots with scaling in the middle; They are raised, erythematous spots with scaling in the middle; This is a spontaneous report from a contactable Other HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. EL3302, expiry date not reported), via an unspecified route of administration on left arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history included pollen allergy. The patient was not pregnant. Concomitant medication included fluoxetine (FLUOXETINE), ethinylestradiol, ferrous fumarate, norethisterone acetate (HAILEY 24 FE); both on unspecified dates for unspecified indications. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685, expiry date not reported) on 20Dec2020 on left arm for Covid-19 immunization. On 12Jan2021, the patient developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back. They are raised, erythematous spots with scaling in the middle. They itch when touched. No ulceration, no oozing. The spots are larger and more red now than when it first began. The patient had nasal swab on 17Jan2021, and it was negative. Outcome of the events was not recovered. The vaccine was given on school or student health clinic. No other vaccines were given in four weeks. No follow-up attempts are possible. No further information is expected.

I had a fever, chills, headache, and fatigue. A week later, I'm still not feeling 100%. The scariest reaction was a rash that broke out all over my chest. I also had one on my forehead. It looked like lacerations and I still have marks left behind. The rash on my chest was very hot and I had trouble breathing at night. I took pictures.

Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, chest, arm; Facial spasms; Fever; Confusion/lightheaded; Confusion/lightheaded; Palpitations; Feeling of being unwell; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization on 22Jan2021, 05:45 PM, at 28-year-old. Medical history included: COVID-19. No allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included: daily vitamins, lisdexamfetamine mesilate (VYVANSE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient left side of body felt very warm and felt like it was melting. The patient had red rash on left side face, neck, chest, arm. The patient had facial spasms, fever, confusion/lightheaded, palpitations, feeling of being unwell, fatigue. All on 22Jan2021, 06:45 PM, and was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit, no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving. Information on the lot/batch number has been requested.

Red splotchy rash on left and right upper flank areas; itching and burning associated with rash; itching and burning associated with rash; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 29-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm, at the age of 28-years, on 21Jan2021 15:30 (03:30 PM) at a single dose as Covid vaccine. Medical history included cyclic vomiting syndrome. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had known medication allergies including diphenhydramine hydrochloride (BENADRYL), propranolol hydrochloride (INDERAL), sumatriptan succinate (IMITREX), metoclopramide (REGLAN), and benzatropine mesilate (COGENTIN). The patient experienced red splotchy rash on left and right upper flank areas, itching and burning associated with rash on 23Jan2021. Treatment was not received for the events. She had no Covid prior to vaccination. She has not had Covid tested post vaccination. The outcome of the events was not recovered.

rash worsened following the 2nd injection. Rash then spread all over body and increased in size; Extremely itchy; Diagnosed as possible pityriasis; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received 2nd dose of BNT162B2 (lot number: EL3249), via an unspecified route of administration in left arm on 20Jan2021 13:45 at single dose for covid-19 immunisation. Medical history known allergies: eggs, shellfish, peanuts. Concomitant medication included desogestrel, ethinylestradiol (APRI). The patient previously received 1st dose of BNT162B2 (lot number: EL0140) in left arm on 30Dec2020 for COVID-19 immunization and experienced rash/mainly on stomach two days after the 1st injection. On an unspecified date of Jan2021, the rash worsened following the 2nd injection. Rash then spread all over body and increased in size. Extremely itchy. Diagnosed as possible pityriasis. Treatment steroid cream received for the adverse events. The outcome of events was not recovered. This case was reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

After first shot on 12/24/2020, I noticed a small rash on my right arm that was quite itchy. After my second dose on 1/14/2021, my rash and itching grew and now I am covered from my neck down to my ankles. I am covered in a red rash/hives, and this is incredibly itchy.

After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is protocol at my hospital to assess for any adverse reactios. About 10 minutes later, I started to feel both of my arms (from should all the way to tips of my fingers) start to get tingly with an intense vibrating sensation. I tried to calm myself down, however numbness began to occur to both BUE seconds after. Next thing that happened, bilateral fingers became visually contracted however numb and I could not move my fingers. I also got a tingly/prickly sensation to my cheeks all the way down to my chin after the hand numbess. The resident doctors quickly took me by wheelchair to a private room where they checked my vital signs. BP was elevated with systolic in 190's, HR around 120s, and my limbs were all cold. By this time it was around 6pm and they were trying to calm me down as I started to have a panic attack. My parents came to pick me up at 7pm when my vitals were stable. I rested at home, and the contraction to my fingers/numbess did not subside until 8:30pm. The following day, my left arm (injection site) had a soreness level of 9/10. Tylenol was used to relieve pain.

I experienced hives on my face that same day in the evening around 7:00pm-7:30pm. I applied aloe vera on face and took Benadryl, after 5-10min my face was cleared.

Moderate soreness around injection site for about 24 hours, red splotches near injection site for about 12 hours

Fever Shortness of breath Chills Unable to move my arm My arm was swollen and red around the area where the vaccine was injected. Sore throat

12 hours after her second COVID-19 vaccine, the patient experience shortness of breath that seemed to be an asthma attack (which she hasn't had in 10 years). She used a short acting inhaler. Then she experienced hives 1 hr after shortness of breath which she treated with benadryl. She was asymptomatic by the morning and has continued to be stable since event.

Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient received the Pfizer-BioNTech COVID-19 Vaccine at 1734. Reported onset of symptoms at 1735 with immediate itching at injection site. Benadryl 25 mg po given and observed for 40 minutes. Felt better after further observation and left the clinic.

Rashes/hives on left wrist, left elbow crease, upper right collar bone, right bicep, right elbow crease, back of the neck, various locations on the back, largest rashes on left and right inner thighs.

Received 1st dose COVID-19 Vaccine at 1705. Ambulated to restroom and noted hives developed on torso and legs with heaviness in chest; denies difficulty breathing. Received MD evaluation in ED. Benadryl 50mg IV and Decadron 10mg IV. Discharged home in stable condition. Instructed NOT to receive 2nd COVID-19 Vaccine. Home with Prednisone and Epi-pen PRN.

A hour post vaccine: rash and itchy all over my body (10 am) At night: fever, chills and bones pain. Dizzy. 11:00 am next day (actual moment): still with fever, dizziness and fever

Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the injection site was the only symptom immediately following the injection. At about 3:00 am the next morning, I experienced extreme nausea and chills. I fainted when I tried to get out of bed to go to the restroom. All of 18 Feb, I experienced the following symptoms: headache/migraine, fatigue, dizziness, loss of appetite, muscle aches/soreness, fever, and severe pain in my left arm. As of today, 19 Feb, I am experiencing headache, lightheadedness, and mild pain my left arm.

10 minutes after vaccine administration, pt developed significant and generalized pruritis, more so over her right arm, but over both upper extremities. She did not develop any signs of respiratory compromise or hypotension, so was given 50mg Benadryl and her itching improved.

Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue

About 30 hours following injection, observed slow to full facial pain on the right side of face and head. Face was mildly inflamed and in pain for approximately 6 hours, then gradually the pain and inflammation subsided. No ibuprofen or other pain relievers were taken at the near the time of adverse event. Ibuprofen (400 mg) was taken at approximately 9 pm the previous evening to reduce arm pain/pain at the injection site.

Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered, No EMS, resolved during extended observation.

Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine. It has now been three weeks and pain has been continuous in the left shoulder and left neck. Pain radiates down the arm and up into the ear, making the ear hurt and making it painful to swallow. The skin is also tender/painful to touch in the same areas, as if nerve damage has occurred. Swelling is visible in the upper back and neck.

Painful arm (could not lift arm) for 2 days Cough Fever Body aches/chills Loss of smell/taste Dizziness Headache Extreme fatigue Neck pain These symptoms lasted approximately 9 days

Hives all over from scalp to toes for over six days; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9262), via an unspecified route of administration in left arm on 22Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19 Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, etonogestrel (NUVARING). The patient experienced hives all over from scalp to toes for over six days on 22Jan2021 22:30. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.

soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration in left arm on 26Jan2021 08:30 at a single dose for covid-19 immunization. Medical history was reported as none. There was no other vaccine administered to the patient in four weeks. No known allergies. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 27Jan2021 at 07:00, patient experienced soreness at the injection site, headache and elevated temperature (100.2 F). Outcome of the events was unknown. Patient was given the vaccine in a workplace clinic. The patient has not tested with Covid since vaccination. Information about Batch/Lot number has been requested.

Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushing, nausea, and tiredness. Flushing quickly resolved but patient reports nausea, abdominal pain, mild headache, and tremors since vaccination. Six days after vaccination noticed hip bruising in the absence of falls or trauma and a cut on the hand that bled more than expected. No respiratory distress or rash noted on exam. Vital signs all within normal ranges. Patient left clinic visit stable and advised to avoid non-steroidal anti-inflammatory medications.

patient reported that approximately 3 hours after receiving the vaccine her face broke out in hives, and was hot to the touch, this lasted all night but went away the following day, patient was deferred from the 2nd shot until cleared by her physician

rash on right breast; swollen and painful axillary lymph node; swollen and painful axillary lymph node; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730; expiration date: unknown) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient medical history was not reported. The patient diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included duloxetine hydrochloride (CYMBALTA), ibuprofen (ADVIL) and birth control medication. The patient first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. On 15Jan2021, the patient had rash on right breast, and swollen and painful axillary lymph node. The patient did not receive treatment for the adverse events. The events were non-serious, and the events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.

Zero adverse effects after first dose. Roughly 10 hours after second dose, I had some body aches, injection site soreness, and headache. I took 650mg of acetaminophen. Roughly 12 hours after the second dose I had increased body aches, injection site soreness and swelling, worsening headache, and nausea. Roughly 18 hours after the second dose, I had chills, a low grade fever, worsening body aches, worsening headache, nausea and vomiting. I took 975mg of acetaminophen. At this time, 27 hours after the second dose, I have body aches, exhaustion, and lack of appetite. I have not vomited in 6 hours and temperature is 99.3.

back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.

"the next day [after vaccination] the injection site was extremely sore and the pain went up to my neck and down into my hand. From what I heard this is pretty normal so I had no concerns. Over the next couple days the injection site pain was gone along with the neck pain but the wrist/hand pain persisted. It?s now been a week since the pain started and my wrist/hand/forearm are still really sore/achy. I?ve been icing it multiple times a day but the pain persists. It?s especially bad when typing or doing any repetitive motions with my hand. "

Fever, muscle aches, chills, sweats, nausea, vomiting, fatigue, tight chest, cough, soreness in shoulder (where I got vaccinated). Nausea lasted about 4 hours, fever lasted about 6-7 hours, aches and sweats lasted about 15 hours, fatigue lasted about 40 hours, chest tightness and mild cough lasted 48 hours and sore shoulder is continuing beyond 48 hours but slowly improving with time

Pruritic red maculo-papular rash in injected are began same evening and progressed to other extremities and trunk over 96 hours. No urticaria, no SOB, no edema. Itching resolved with adequate doses of diphenhydramine followed by rash resolution.

18-40 hours after getting vaccine: sensitivity to light headache with light activity (walking more than 5 minutes) fatigue muscle/joint pain injection site swelling and redness soreness at injection site (lasting 48 hours +)

I noticed some hives on my arms, face, and chest area at around 3 or 4pm, and next day it was still present but a little red. It?s better but still here.

Pfizer-BioNTech COVID-19 Vaccine EUA I received the Pfizer vaccine a week ago from today and I believe I am having a mild allergic reaction to it. I have two very itchy bumps on each of my ankles, one under my right knee, and two on my left arm. The bumps formed almost immediately after getting the shot and was itching before I made it home. The bumps on my ankles are now larger than they were last week. The one under my knee just got there within the last few days. The itching has seem to have gotten worse because it woke me up out of my sleep over Monday night.

Red bump appeared and where itching at injection beginning 3/6/21 At 7am And ending 3/8/21 around 430pm. I took benadryl to relieve temporarily until it went away on its own.

Redness, swelling, and itching at site of injection starting 5 days after injection and ending 6 days after injection.

"She is a 28 year-old female calling today with a chief complaint of a rash. Her symptoms started about three days ago. She got her first Pfizer covid-19 vaccine last Thursday, 5 days ago. 2 days later she started to develop some itching on the bottom of her foot and then shortly after started to develop a blotchy rash on the foot. She woke up today and now has a rash over the majority of her body, it is under her arms, on her chest, her knees, her sides, upper back, inguinal area and legs. She is not having any trouble breathing or swallowing. There is no chance she is pregnant. The rash is not itchy except for the small area on her foot. She took Benadryl once the first night she had some itching which helps."

Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneous report from a contactable other hcp (reporting for herself) A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration single dose on 06Feb2021 10:15 (at the age of 28) left arm for covid-19 immunisation. The first dose (lot# EL12849) was taken on 15Jan2021 10:15 am, left arm. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced muscle aches on 06Feb2021 19:00, injection site pain on 06Feb2021 19:00, headache on 06Feb2021 19:00, flushing in face on 06Feb2021 19:00, brain fog on 06Feb2021 19:00. No treatment received. The events outcome was not recovered.

Patient received her 2nd dose of Pfizer Covid-19 vaccine, Lot #EN6199, in her left deltoid on 3/11/2021 at approximately 9:24am. Patient disclosed to nurse and medic at vaccination clinic that she had allergies to peanuts and eggs and would need to wait in the parking lot longer than usual. Nurse and medic confirmed this and advised she wait a minimum of 30 mins but longer if she felt necessary. While waiting in the parking lot, at approximately 10:25am, patient began to have shortness of breath and made the medics aware. Patient also had facial redness and nausea. Medics administered 50mg of Benadryl , 0.3ml Epinephrine, and started IV with IV fluids. Patient was transported to Medical Center.

Reports itching to face & arms beginning at 1224 Administered 25mg Diphenhydramine with relief. Cleared to leave at 1310 with reported improvement of itching.

Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and internal tremors, which resolved. I later developed generalized itching, worse on the back of my hands and feet, which resolved. The following day, I developed palpitations while at rest and mild shortness of breath. I also had a brief bout of nausea, which resolved, but I still have palpitations and mild shortness of breath.

Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fatigue, migraine, un-productive coughing, chest tightness, difficulty breathing.

Nausea, exhaustion, lightheaded/ dizziness, sore arm around injection site, light headache. lots of rest and hydration. symptoms lasted for 48 hours, only beginning the morning following the injection, (sore arm began right away).

First dose: Had a very slightly sore arm a few hours after injection through the following morning. Then had a very slight headache for a couple hours. Then the day after that my neck was very sore on the side the vaccine was given. I watched TV on my laptop and had my elbows on my thighs for maybe 30 minutes and I often watch TV like this. When I went to the bathroom, I saw my thighs had multiple bruises where my elbows were (3 spots) while I was watching TV. The bruises and sore neck lasted another 2 days and I was fatigued more quickly during this time. After that I was fine, though 1 bruise spot still remains today 11 days after vaccination. The easy bruising and lasting bruising is not normal for me. I have dark color skin and also rarely bruise.

Itchy swollen fingers and palms the following morning (Thursday, 3/11). Red itchy bumps (hives?) on left wrist, then later on right wrist. Heels and feet had same reaction on Friday. I took Benadryl and was OK for all of Saturday. Today (Sunday, 3/14), I broke out the same rash but one my face, mostly around my jaw and hair line, and my neck. Some coughing and wheezing, which I had not been experiencing prior

Strong pain in deltoid muscle beginning the evening of the first injection (3/12) and the day after (3/13). Impossible to sleep on that arm, difficult to lift arm, severe pain when touched. Diminished pain 3/14-3/15.

Shingles; This is a spontaneous report from a contactable consumer or other health professional. A 28-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EN5318) via an unspecified route of administration on 11Feb2021 in Arm Right at single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy (seasonal allergies) from an unknown date and unknown if ongoing. Historical vaccination included at age of 28 years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EL3247) on 21Jan2021 in Left arm at single dose for COVID-19 immunisation. Concomitant medications included cetirizine and fluticasone propionate (FLONASE) taken for an unspecified indication, start and stop date were not reported. On 14Feb2021, The patient experienced shingles. The action taken in response to the event for BNT162B2 was not applicable. Therapeutic measures were taken as a result of shingles. The outcome of event was recovering.

Nausea, vomiting and bodyaches. Employee states her Left arm is swollen from injection site down to her hand. Arm is very painful to move.

1450- pt requested assistance for tachycardia, tingling lips and dizziness. Requesting benadryl, 50mg given PO. VS 128/54, P90, 20R, 98% sat. 1500- increased dizziness, throat tingling. VS 130/89, 104P, 24R, 98% 1508- increased throat tingling, "hard to breath" declines epi or EMS to be called. 1511- self-administered epi pen, EMS notified. 1516- remains light-headed/dizzy, resp adequate at 22/min, O2 sat 98% 1524- speaking clearly, remains fully conscious. Resp regular. Lungs CTA, MM pink. VS 130/70, 83P, 20 R, 98%sat 1530- Await EMS arrival. Pt able to easily talk on phone with family member. Still c/o itchy throat and lips. 1535- EMS here, pt escorted out building with EMS at 1537.

I had chills, body aches; headaches; I felt feverish but I don' t know if I had a fever. Body aches were really intense - I didn't sleep the whole night. I had swelling a little on my arm - at injection site. My arm was sore. In general, my body was really sore and I couldn't get up from bed for 24 hours. I still had a bit of a headache and chills after the 24 hours so I stayed home from work 48 hours. I have been seen by a doctor -after the second vaccine, I had a flare up with my rash on my face (had been experiencing a rash on face prior to vaccine but this was a flare). My face flare up was that I broke out in a rash after finishing doxycycline. Didn't put me on another antibiotic because they wanted to wait and see with the rash - and the tests. Flare up - I couldn't eat; painful to wear a mask to work; couldn't sleep on my face. I was put on doxycycline again - on March 10th or 11th again because I couldn't handle the pain anymore. And it is getting refilled for another round. I have had to take a leave a absence from work the last two weeks.

1 week after my second dose I start developing hair loss, specifically alopecia Areta; 1 week after my second dose I start developing hair loss, specifically alopecia Areta; This is a spontaneous report received from a contactable 28-year-old female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: El1284, dose number=2) via an unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: Ej1685, dose number=1) via an unspecified route of administration on 18Dec2020 10:30 AM at single dose for Covid-19 immunization. As per the adverse event description, one week after her second dose on 15Jan2021, she started developing hair loss, specifically alopecia Areta resulted in doctor or other healthcare professional office/clinic visit. She took unspecified steroid injections to scalp. The outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.

Erythema of bilateral facial cheeks and right neck. Of note, patient had mild facial erythema after first vaccine dose. Received Benadryl 50 mg pO.

815am - notice entire left arm is swollen and red, a few minutes later extreme nausea, dizziness, chills, which lasted about 20 minutes. Fatigue and aches followed which slowly faded and were gone by about 4pm

About 30 minutes after receipt of the first dose of the Pfizer COVID vaccine, my upper lip was slightly swollen on the same side as where I received the vaccine (left), and I had redness in my face for about 1.5 to 2 hours. I also had a slight lump in my throat 15-30 minutes after receipt. I never felt like I was in danger or needed immediate medical attention, and the symptoms subsided without medication.

feeling faint and hot; feeling faint and hot; the patient began to experience lightheadedness; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other health care professional. A 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration on 12Mar2021, as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitants were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The reporter stated that, during her 15-minute waiting period after the injection, the patient began to experience light-headedness and feeling faint and hot. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. The patient received water, snacks and ice packs as the treatment. On an unknown date in Mar2021 the patient had differential diagnosis systemic reaction (hypoglycemia, hypotension, generalized rash). The reporter stated that that the patient having improvement of symptoms after observation in medical bay for 40 mins. She was to be taken home by her father who was able to come in to pick her up. The reporter stated that the patent wheeled to front by this provider and able to stand and walk assistance to car and she was monitored symptoms at home and follow up with PCP as needed. Outcome of the events was recovering. No follow-up attempts are possible. No further information available.; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

12 hours post vaccine: Developed fatigue, nausea, chills, body aches. No fever recorded. Injection site felt hot and swollen but did not appear swollen. 18 hours post vaccine: Took 1000 mg tylenol and went back to sleep 20 hours post vaccine: Woke up feeling better, went to work 24 hours post vaccine: Developed bad headache, fatigue and nausea again 30 hours post vaccine: Took 1000 mg tylenol and 500 mg ibuprofen 32 hours post vaccine: Almost all symptoms gone, only mild residual injection site soreness still present

13 weeks 6 days at time of injection, 14 weeks 0days at onset of symptoms. Body aches and chills started at 1am. Vomiting started at 2am and last until 4p. Was unable to keep food or liquids down during that period. Had highest fever of 100.7 F, as well as nausea, body aches, chills, fatigue and severe pain at injection site. Nausea and fatigue continued into day 2 after getting vaccine (3/27).

From 9:30-11am significant decline from minimal symptoms to headache, body ache, soreness at site of injection, fever (99.5°-100°). At 12pm took acetaminophen 325mg x2, reduced symptoms to manageable discomfort and no fever. Symptoms (incl fever) returned by 6pm, took another round of acetaminophen 325mg x2, which again helped through bedtime. Slept through the night, no fever next day.

On 03/25/2021 client states she waited for her 30 minute waiting period following vaccine and about 10 minutes after leaving started to develop hives on hands/wrists/arms that continued spreading to sides and lower back. Client notified Health Dept on 03/26/2021, and client enouraged by writer to seek medical care. Writer spoke with client on 03/29/2021 and client states has not sought medical care or assessment. States she has no SOA, swelling, coughing, wheezing or any other s/s of adverse reactions. States hives remain.

Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling worse; Some feverish feelings; Hives all over my body, especially on my face; Chills; Couldn't stop shaking; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in arm left, on 26Mar2021, at 14:00 as single dose for COVID-19 immunisation. Patient medical history was not reported. She did not have any known allergies. Concomitant medications included estradiol valerate, progesterone and cyanocobalamin (VITAMIN B12). Patient stated that she first experienced some feverish feelings, chills and hives 30 minutes following her vaccination. She drove home from the hospital and was feeling a bit off, but mostly okay. By the time she got back, she was feeling worse, around 4 PM. By 5 PM she had broken out in hives all over her body, especially on her face, swelling her eyes significantly and having her tongue go somewhat numb, starting to make it difficult to swallow. She also had significant chills, and couldn't stop shaking, and ended up being admitted to the ER. After being given antihistamines, the swelling went down and eventually the chills stopped after monitoring in the hospital. The patient was hospitalized for the events on an unknown date in Mar2021. Treatment received for the events. The patient was not diagnosed with COVID prior vaccination. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. Outcome of the events was recovered on an unknown date in Mar2021.

Fever, chills, muscle aches, teeth chattering, painful to touch all over body, exhaustion. Starting around 11:30 pm. Fever and chills subsided around 3:00 am on 4/26. Muscle were sore and body aches until around 11:00 am 4/26. Tired and drowsy all day 4/26.

Itching near site of Injection. Itching then spread down the arm to the elbow area. Itching on neck and side of face. Itching also on back and legs. Itching persistent for 30+ minutes

injection site soreness; general body aches; upset stomach; This is a spontaneous report from a contactable consumer (patient's guardian). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07Apr2021 at 16:15 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Mar2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 19:00, the patient experienced injection site soreness, general body, aches, upset stomach. No treatment was received for the adverse events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Hives; This is a spontaneous report from a contactable consumer (patient's husband). A 28-year-old female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3247, expiration date May2021) via intramuscular administered in left arm on 08Feb2021 (at the age of 28 years old) as single dose for COVID-19 immunisation. The patient medical history included Chronic kidney disease (May2018), helps to lower protein in urine, iron was low, autoimmune disease, to stabilize the kidney. Patient got flu shot last year, months ago. Concomitant medications included Losartan50mg tablet twice a day by mouth used for chronic kidney disease, helps to lower protein in urine, Ferrous sulfate 325mg tablet, one tablet twice a day by mouth and Azathioprine 50mg tablet once a day by mouth. On 11Feb2021, the patient had experienced hives. The adverse event was not resulted in emergency room. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. Additional Context included Caller is the husband of the patient. His wife received the first dose of the vaccine on Monday 08Feb2021. She woke up today with itchy bumps around 7am this morning. She went to the dermatologist today at 1330 and the dermatologist confirmed it was hives. States nothing has changed with her aside from getting the vaccine. She has never had hives before. Treatment: She is prescribed a topical cream which has not been picked up yet, she was told take a Zyrtec Outcome: The hives are moving into different areas, some areas of the the itchiness has gone away and she is getting new bumps in different areas. HCP: declined to provide, she is going to see a different primary, she usually just sees her nephrologist Her nephrologist and rheumatologist work together in regards to her medications. She got the flu shot last year, months ago. The outcome of the event was not resolved.

Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles breakout migraine to the point of a blackout on 18Apr2021. There was no treatment received for the events. The outcome of the events was not recovered. Information about lot/batch has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the report migraine to the point of a blackout and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.

Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue

Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia that self resolved after about an hour. This was followed by about 2 days of fatigue and myalgias that interfered with my daily activities that also self resolved. Had a large tender reaction on my left bicep for about 5 days after the injection.

About 12 hours post vaccination, I developed body aches and fever and chills which persisted for another 48 hours. I had taken Tylenol 1000mg q6 hours about 14 hours after the vaccine for until Saturday. 72 hours post vaccine, body aches and chills are gone, only intermittent headaches that come and go. As of 1/3, 4th day post vaccination I have a red bump under the injection site, it is not raised but it is red and warm to touch and it still hurts while moving my left arm.

Elevated heart rate within the first five minutes after injection. Went away in about one minute. Came back for about one minute in five minute intervals for a duration of about 40 minutes after injection. Feeling flushed with the first 15 minutes after injection. Soreness at injection site 24-48 hours after injection.

developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Jan 05, 2021 : Dr.: Established Patient Video Consult :Video Consult Search Notes EditExportPrintReportsFaxRx1 of 1 Age29Visit TypeEstablished Patient Video Consult DateJan 05, 2021StatusUnsignedProviderDr. Signed by-- Subjective Chief Complaints Pfizer vaccine last Tuesday on Left arm.. 1.5 days later on opposite arm around elbow. Chief Complaint Rash History of Present Illness Location of symptoms: Generalized body, Chest, Abdomen, Upper Extremities, Right, Left Timing: Worsening on prednisone and famotidine oral treatment

Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.

Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.

some redness was noted at injection site; Pain at injection site; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot number: EL0140), intramuscular in Left arm on 24Dec2020 at 11:45 am at single dose for COVID-19 immunisation . Medical history was none.No known allergies to medications, food, or other products. There were no concomitant medications. On 24Dec2020 at 10:00 pm (as reported) the patient experienced pain at injection site and on 25Dec2020 some redness was noted at injection site; events were reported as non-serious and described as follows: pain at injection site, started 10 hours after vaccination (as reported), lasted 24 hours. Also some redness was noted at injection site a day after vaccination, that self resolved in 2 days. Patient did not need to take any pain medication, no treatment given for the events. Patient recovered from the events in Dec2020.

Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.

I received the first dose and one week later I formed a rash on my lower legs and a fever. The doctors suspect Erythema nodosum but the tests are still pending.

Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.

I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful confluent blanching rash on 12/18. So far I have not has SOB, fatigue, N/V - any other systemic sx.

Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

On 1/3 I developed a rash along my right side, under my right arm pit and along right breast. This progressed the following days, became itchy and painful. The pain was shooting. I saw my PCP office on 1/6 and was diagnosed with Shingles.

~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, fatigue, muscle soreness, headache

6 hours post vaccine patient developed a bad headache; 12 hours post vaccine patient developed a temperature of 102 degrees tympanic; 36 hours post vaccine patient developed hives on both feet. 48 hours post vaccine patient's headache and fever were gone and mild hives remained on the feet.

Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report from a contactable Other Health Professional (Physician Assistant). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she is treating a patient in ICU that got the COVID-19 vaccine on 29Dec2020. The patient developed hives in the first 10 minutes of the vaccine and had an anaphylactic reaction 1 hour later. Seriousness of events was reported to be hospitalization. Outcome of the events was unknown. The reporter also mentioned that it was not a mild reaction and patient was still in the ICU, 48 hours later. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction and hives cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 144; o2 99%, RR 16. She was given albuterol inhaler x 3, Epi-pen x 1, benadryl 25 mg with some iprovement. She was sent to ED. PMHx: tree nut allergy, Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS; Taken to ED

I got the injection on my right arm & on my elbow area it was really painful it was like a broken arm because I couldn't do anything with it. Seen doctor on 12/24/2020

I got the shot on the top of my right arm but on my right elbow area was really painful it was like a broken arm because I couldn't use it I couldn't do anything with it but it got better after 4 days. Seen doctor on 12/24/2020.

Left axillary lymphedema (swollen under arm pit). Can?t sleep on that side or lay arm flat on that side. Right side is perfectly fine. Slight left neck swelling also. Significant injection site pain with mild redness and swelling. Joint/muscle pain. These events also occurred after my first covid Pfizer but not until day 4-5 and very mild. I have not taken any medication as of yet.

Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day, continuing for days; Fatigue; This is a spontaneous report from a non-contactable other HCP. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included endometriosis. There were no concomitant medications. The patient experienced Mild nausea shortly after injection. Injection site soreness beginning in the afternoon of that day, continuing for days and Fatigue on 04Jan2021 12:45. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine. Outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards of glass. By day 3, swelling in left arm and lymph nodes under arm, armpit, and side of breast. Tingling in left arm down to fingertips and "dead arm" feeling.

Patient described Rash and itching approximately 2.5 hr after she received the pfizer covid -19 vaccine first dose. She received 1 dose of Diphenhydramine 25mg po. Few minutes later she complained difficulty sallowing and given Epinephrine 0.3mg IM and EMT was called in. She was transported to ER by EMTs

red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadryl after symptoms continued. After the second dose of benadryl, s/s subsided enough for the staff member to go home.

After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 hours starting 4 hours after shot. After first dose: injection site pain the next day

Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by medication that lasted 24 hours. Fatigue that lasted 24 hours. Severe injection site pain that lasted 12 hours. Nausea that lasted about 12 hours.

Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. Round, erythematous, flat, tender area on arm about 2 cm inferior to injection site. First noticed 3 days after vaccination.

Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot

Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine administration. Bone pain, lymph node swelling, headache for 36 hours post.

About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.

Experiences rash on the face and hives on body, two days after receiving the second dose of the Pfizer vaccine. Took diphenhydramine and applies hydrocortisone cream. Reaction resolved after one and half day

Injection site turned red, hot, and slightly itchy on 1/11/2021, one week and two days after receiving the first dose of the vaccine.

Intense pain upon injection not felt with any other form of vaccine. Pain in arm continued to get worse throughout the day. Unable to lift my arm very far without pain. Worse than any other injection recieved in the past. Pain throught the night-causing lack of sleep. Severe pain for about 24 hours or so then completely gone. My muscle in my arm then felt tight as if there was inflammation of some sort or an injury to the muscle. Upon lifting my arm it felt as if my arm was pulling back. No pain during this action but more of a weakness. No relief from anti inflammatory medicaiton or ice. Sensation in arm noted to be gone on 01/09/2021.

Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, fatigue, injection site tenderness, and swollen lymph node to right neck, started morning after vaccine and resolved by second day after vaccine. Took Tylenol twice. Swollen lymph node under right arm, starting morning after vaccination; has reduced but remains present.

Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. Fatigue and exhaustion. Body aches. Headache.

Soreness at injection site began a few hours after administration. By the evening I began experiencing headache and an overall malaise feeling. This progressed into chills to the point of shivering and feeling feverish. Overnight I developed another headache and felt very mildly nauseous in addition to feeling fever/chills. Overnight I took 3 OTC Advil, was bundled up under multiple blankets, and got lots of rest. The next day I felt much better, only some fatigue.

Started as itching at the injection site approx 35 minutes after shot which led to generalized itching on left arm, chest, and back when another colleague examined my back and noted hives. Became slightly short of breath and felt my heart was racing. Took 25 mg of oral Benadryl and told to go to ED. In ED heart rate was 126 bpm and BP WAS 136/99. Monitored in the ED for a few hours with no further interventions. Heart rate improved to 102 bpm and blood pressure to 129/82.

Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse throughout the day. Temperature at 10:00 pm (14 hrs after injection) was 99.1 degrees Fahrenheit. Went to bed and woke up the next day feeling better. Slight sensitive skin, sore neck, and headache. Did not urinate for 9 hours.

During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.

Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10 hours after Left side Lymph node pain-onset morning after Joint pain-onset 10 hours after Body aches-onset 10 hours after

Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.

have pain in my left arm where it was administered the vaccine/the area was red and inflamed; have pain in my left arm where it was administered the vaccine/the area was red and inflamed; pain in my left arm where it was administered the vaccine; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient experienced started to have pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00. The next day (16Dec2020) the area was red and inflamed. The redness and the inflammation lasted three days. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events 'redness and the inflammation' was recovered on 19Dec2020, outcome of the other event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

11 hours after administration, I experienced chills without objective fever, myalgias, localized injection site muscle soreness, headache.

After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for about 36 hours from onset time listed, significant headache and fatigue for 48 hours from onset time listed

I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown. Information on the lot/batch number has been requested.

I got a rash, I felt like it started on my legs and spread everywhere. It spared my face, neck and back. I went to the Doctor . The Dr gave me a steroid shot and some cream to help with the itch. The rash went away about two days later.

On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness with intermittent slight rash. On 1/7/2021 she developed severe muscle pain, joint pain, fever, and intermittent lightheadedness and dizziness. She went to the emergency room on 1/10/2021 but no changes made in medications. She reports her BP was 207/111 and her pulse was 165/minute and still runs that high now. She had hypertension and tachycardia. About 1.5 years ago she had a history of hypertension and tachycardia. 1/12/2021 this person continued to have hypertension and tachycardia. Instructed to make an appointment to see her primary physician.

This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated she had a fever of 102. Her body ached all over from head to toe. She had dizziness with an intermittant rash. She did go to the emergency room on Sunday 1/10/2021 with hypertension and tachycardia. Her BP was running at around 207/111 and her pulse has stayed around 165 even through today on 1/12/2021. She did state about 1.5 years ago she experienced tachycardia and hypertension but not since. She did not get any new medications upon her visit to the emergency room. She was going to try to see her physician today if possible on 1/12/2021.

Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness

fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the injection site began within a few minutes and gradually increased reaching it's maximum around 8 hours after the dose.; Neck pain was also significant; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 12:00 PM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 09:00 PM (Arm Right) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included asthma and generalized anxiety disorder (GAD). The concomitant drug was reported as Escitalopram. The patient experienced pain in the injection site began within a few minutes (05Jan2021 12:15 PM) and gradually increased reaching it's maximum around 8 hours after the dose. Neck pain was also significant (05Jan2021 12:15 PM). Fatigue, malaise and mild headache started around 10 hours (05Jan2021 22:00) following vaccine administration. Almost 24 hours following administration (06Jan2021 12:00) a fever of 38 C started and persisted for about 6-8 hours. It subsided but severe fatigue and malaise (that prevent me to do daily activities) are still persisting greater than 48 hours following administration. The outcome of severe fatigue and malaise was not recovered. The outcome of Headache, Pain in the injection site, Neck pain, fever of 38 C, was recovering. No treatment received for the adverse event. No COVID prior vaccination and no COVID tested post vaccination. Information on Lot/batch number has been requested.

1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall skin sensitivity 48 hours: respiratory symptoms- cough, sore throat, runny nose, congestion

1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16. Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest, does not report signs of itchiness but does feel warm, window opened nearby, cont. to monitor staff member, 1320: staff member reports she feels better. 1309: staff member rechecked by pharmacist,

I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.

Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.

On 1/14/2021 at 0630am, I noticed my armpits were bright red, with no raised rash, and warm to the touch. There is a sensation of warmth and feeling "full" in this area. At this time, no treatment has been taken as it is not uncomfortable. It is 1:45pm, and all symptoms are still present. The warmth sensation has slightly increased throughout the day. I have had bouts of chills throughout the day, but no fever or headache.

Patient received first dose of Pfizer COVID-19 vaccination last evening. This morning, she awoke and went to the bathroom at approx 0700 and noticed the red, raised rash throughout her lower extremities. She further noticed the same pattern distributed throughout her entire body including scalp. She endorses only very mild to no pruritis and denies associated pain. She does endorse mild chills and malaise noticed last PM following the shot. In addition, at her office visit this morning, she had a low grade fever of 100.2 measured. She given ibuprofen in clinic, as well as recommended ibuprofen, acetaminophen and prescribed famotidine, loratadine, and diphenhydramine for her symptoms and instructed to follow back up at the clinic tomorrow. Photos were taken of the rash and sent by patient to appropriate contact.

Person giving the injection gave it in the back of my arm, almost as if she was giving a sq injection. They used the 1in needle so I think she got into my tricep but it was nowhere near my deltoid. I have injection site soreness which is why I think she even got to the muscle but I have none of the classic immune reaction symptoms. I wanted it on record in case it was not thoroughly absorbed and then I wouldn't be covered. I figured with this being so new every mistake matters. I'm going to try and get an antigen test in 2-3 weeks.

THE PATIENT RECEIVED HER 1ST DOSE OF THE COVID-19 VACCINE AND WAS OBSERVED BY MATHER STAFF FOR THE REQUIRED 15 MINUTES WITHOUT INCIDENT. SHORTLY AFTER LEAVING THE VACCINATION POD THE PATIENT BELIEVED TO BE HAVING A REACTION TO THE VACCINE AND PRESENTED AT MATHER EMERGENCY DEPARTMENT FOR EVALUATION. A SCATTERED RASH TO HER RIGHT FOREARM, RIGHT FACE & CHEST WERE NOTED BY THE CARE PROVIDERS. THE PATIENT RECEIVED BENADRYL 50MG BY MOUTH X 1, WHICH EFFECTIVELY RESOLVED THE SIGNS & SYMPTOMS.

Covid vaccine on 1/11/2021. Tested positive for covid 1/13/2021. Developed lip swelling, hand/feet swelling and itching on 1/14/2021. Improved with benadryl.

Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.

Pt received dose second Pfizer COVID vaccine. Reported pruritus all over her body - patient was noticeably scratching herself. Patient was given 12.5 mg benadryl and was observed for an additional 15 minutes. Patient reported still having pruritis and was given an additional 12.5 mg benadryl, and was observed again for an additional 15 minutes. At the end of the 15 minutes she reported feeling much better and was sent home.

The area where I received the injection was very sore for approximately 4 days. A week after my first dose, the lymph node in my left armpit became painful and swollen. Also, the injection site has a 2? round, bruise that appeared a week following the injection.

whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.

Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I woke up with severe chills and had a fever of 102 degrees F. Also had joint pain in knees/ankles and thigh muscle pain, as well as injection site pain. Around 9 am, fever had increased to 104.4 degrees F. After taking 1000 mg of Tylenol, fever decreased to between 100 and 101 degrees F. Around 3 pm, fever was still above 100 degrees F so took 400 mg of ibuprofen. By 5 pm, fever was finally below 100 degrees F. By 1/16/21, all side effects had resolved except lymph node in injection arm was significantly swollen, hot, and tender. By 1/17/21, side effects still resolved besides swollen and tender lymph node.

Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.

I experienced throat swelling itching and hives as a result of my covid vaccine. The vaccine was given 1/6, symptoms occurred 1/7 overnight.

I was asleep I woke up coughing. Feeling like I swallowed my necklace( it felt like there was a string in my throat) and labored breathing. Rash developed all over body that is similar to the rash Kawasaki syndrome kids get. Was taken to emergency room where I was given iv steroids and epi. 10-15 mins after my breathing was back to baseline and throat felt better. I have never had any trouble breathing or any allergic reactions to anything in the past.

Rash was pruritic and diffuse/one day later became less itchy and more macular papular in nature; Developed urticarial rash; Rash was pruritic and diffuse, spread to extremities, back, trunk and face; This is a spontaneous report from a contactable physician (patient). A 29-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9898; expiration date: unknown), intramuscular left arm on 21Dec2020 16:00 at a single dose for covid-19 vaccination. Medical history included depression and anxiety. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) and escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital on 21Dec2020 04:00 PM. The patient developed urticarial rash about 2 weeks (05Jan2021 07:00 AM) after receiving vaccine. The rash was pruritic and diffuse that spread to extremities, back, trunk and face. About one day later (06Jan2021), it became less itchy and more macular papular in nature. No other symptoms. No airway swelling. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment for the adverse events. The outcome of the events was recovered in Jan2021.

Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, …she was bleeding from that scar; hit her nose, got the scar in the nose, …she was bleeding from that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown. Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine was given; This is a spontaneous report from a contactable Nurse (reporting for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, bacth/lot no: EK9231 while expiry date was unknown), intramuscular on left deltoid on 07Jan2021 16:45 at a single dose for covid-19 immunization. There were no medical history and concomitant medications reported. Patient has no prior vaccination within 4 weeks.The patient got her first dose of the COVID 19 vaccine yesterday (07Jan2021) from her employer. She started "feeling yucky" today (08Jan2021) around noon with a low grade fever,and developed a cough that was not persistent. Patient has soreness in the arm where vaccine was given. She was asking what should she do about it? Outcome of the events low grade fever, cough, feeling unwell, feeling abnormal were not recovered while vaccination site pain was unknown. The events low grade fever, cough, feeling unwell were considered serious medically significant and related to vaccine.; Sender's Comments: Based on the time association, the events fever, cough and malaise are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

patchy hives, itchy, turned into head to toe hives with swelling. Treated with 50mg Benadryl injection and solumedrol injection. 4 hours later upon waking up symptoms had resolved. given prednisone pack to treat as well and oral benadryl prn for itching.

0931 Client felt hot at back of neck; States she has a hx of panic attacks for which she takes Ativan PRN; States this feels the same; BP 140/95 P90 R 15; SpO2 99%; Resp unlabored; Lungs clear - no wheeze or stridor; Skin warm pink and clammy; LOC A&O x 3 0932 EMS notified; ice pack provided for back of neck for comfort 0935 P 75 SpO2 99% ; Client states she is feeling a little better 0940 BP 118/86 P 84 R 12 SpO2 99%; Resps continue unlabored; LOC A&O x 3; juice provided 0945 EMS arrived; BP 138/96 P 90 SpO2 99%; Client is feeling nervous again b/c EMS is on scene; Hand off report given to EMS. 0951 EMS retrieved Ativan from client's vehicle and allowed client to take usual dose; client feeling better; EMS departed without the client 1000 Client states feeling well enough to leave; Resps unlabored; A&O x 3

AE's : Injection tenderness, fever, chills, headache, malaise, severe myalgia, lymphadenopathy, mild sore throat, occasional nausea and lightheadedness when standing for longer than 5-10 minutes at a time. Tx: none Outcome: All AE's except injection tenderness and right axial lymphadenopathy fully resolved within 48 hours.

Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Extremely uncomfortable, from neck to back to calves, without improvement with Tylenol or ibuprofen, causing me to be unable to sleep. Around hour 20 post-vaccine, I started to get chills. It wasn?t just feeling cold or shivering, it was full body convulsions that lasted approximately 15 minutes. I became nauseas and dizzy after that for about an hour, unable to stand or walk anywhere. The severe body aches continued, with no improvement from Tylenol or ibuprofen or heating pad. Aches resolved around hour 30 post-vaccine and the only symptom left was pain at the injection site.

On January 15, I developed urticaria to my face and neck, with a faint papular rash on my forearms also. On Jan 16, I developed facial edema with continued rash which worsened throughout the day despite Benadryl. On Jan 17, the rash was improving, but the facial and neck edema had worsened to the extent that my eyes were nearly fully closed. I presented to the ED and received treatment for allergic reaction, including Epinephrine, steroids, and histamine blockers. I have no known allergies.

Swelling at injection site; inflammation around injection site; This is a spontaneous report from a contactable physician, the patient. This 29 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via intramuscular route of administration in the left arm on 23Dec2020 at 02:15 PM (at the age of 29 years-old) for COVID-19 vaccination. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There was no relevant medical history reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) dose 2, single dose via intramuscular route of administration in the left arm on 08Jan2021 at 11:00 AM and experienced headache, nausea, pain at the injection site, fever/chills, bodyache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste and inappropriate schedule of vaccine. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient experienced swelling at injection site and inflammation around injection site. The events were reported as non-serious. The patient was not treated for swelling at injection site and inflammation around injection site. The clinical outcome of swelling at injection site and inflammation around injection site was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information of lot/batch number has been requested.

Vaccine administered too high in right arm by CP. At time of administration pt felt severe burning and pain at and around right shoulder joint. After vaccine administered there was hardly any R upper arm muscle pain noted. All pain was located in the right shoulder joint 9/10. Pt unable to move or use R arm/shoulder for approximately 3 days post injection. Heat applied several times a day, arm/shoulder rested and ibuprofen 800mg taken every 6 hours. Small range of motion exercises attempted to help alleviate stiffening. Approximately 4 days post injection- very small range of motion returned 25% of baseline- still unable to use right shoulder to complete daily tasks, pain 7/10 in right shoulder joint. Pt continued to use heat, rest and ibuprofen 800mg. No muscle pain noted in right upper arm. As of 1/19/20- range of motion about 50% in right shoulder, pt has clicking and popping in right shoulder joint with all movement. Pain 5/10 in right shoulder joint with movement. Pt unable to lift object more than approximately 3lbs. Ibuprofen 800mg still taken PRN pain, heat still applied PRN. All symptoms reported in Vsafe app following injection. 1/19/21 Notified hospital through COVID question hotline- RN charted problem in pts medical record. Pt concerned because there is not a significant improvement 10 days post injection. Also due to the lack of information about adverse events of the Pfizer COIVD 19 vaccine.

5 minutes after receiving the second Pfizer COVID19 vaccine, it reportedly felt difficult to swallow, tongue felt large. Epi Pen administered and IM Benadryl. She was then transported to ER. On route, felt throat irritation, sore and a little bit of itchiness all over but no hives. She was observed in ER x 4 hours and released.

Approx. 2x2: painful, red, warm, raised area at injection site; Approx. 2x2: painful, red, warm, raised area at injection site; Approx. 2x2: painful, red, warm, raised area at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 29-year-old female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on 18Dec2020 (lot number: EK5730) and second dose on 08Jan2021 (lot number: EK9231), both intramuscular in the left arm (injection placed approximately 8" below acromion process, medial side of arm, not into deltoid) at single dose for COVID-19 immunization. Medical history included asthma and covid (reported as "if covid prior vaccination: Yes"). The patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), sertraline hydrochloride (ZOLOFT), and melatonin. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL), and both experienced with known allergies. The patient had not tested for COVID post vaccination. The patient experienced approx. 2x2: painful, red, warm, raised area at injection site on 09Jan2021 04:00. No treatment received for these events. The outcome of the events was recovering.

Began about 1.5-2 hrs after vaccine Hives, red rash all over face and body. Fever of 103 disoriented trouble breathing and speaking and remembering. Dizzy. Alternating high and low blood pressure. Chills. Body aches. Sore tenderness and warmth at injection site. Sluggish speach

Hives presenting on the face that improves slightly with taking PO Benadryl. Hives still present after two days from initial presentation. Continued use of Benadryl is needed.

Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of the vaccination. Day after vaccination I have fever, nause, joint pain, chills, and the pain in the arm persists.

Pfizer-BioNT Tech COVID-19 Vaccine EUA. Rash of bumps on the left arm where injection occurred as well as a rash on right side of neck some difficulty breathing. Albuterol and Benadryl were taken to address the reaction.

Hives; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142; Expiration date was not reported) on 30Dec2020 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included asthma, gastroesophageal reflux disease (GERD) and allergy to sulfa drugs. Concomitant medication included omeprazole. On 06Jan2021 (20:00), the patient had hives. The hives was further reported to have occurred in two instances: first was 14 days after receiving the vaccine, and the second was 17 days after vaccination (pending clarification on event onset date). The patient did not receive any treatment for the reported event. The outcome of the event, hives, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.

Less than 24 hours after the vaccine, I had hives all over my body. Face, neck, stomach, back and legs. They have lasted for 48 hours and have not gone away.

Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. 3 weeks post injection.

Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.

7 days after the 1st dose of the covid Pfizer vaccine, I developed symptoms at the injection site on my left arm that included mild tenderness, moderate itchiness, severe swelling, and severe erythema. At the start the swelling was approximately 6.5cmx 7cm. We drew a circle around the swelling and by the end of my shift (12 hours later) the swelling and redness at exceeded the original circle we drew. I had no other symptoms systemically, only at the injection site.

Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), intramuscular in the left arm on 11Jan2021 12:30 at a single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), intramuscular in the left arm on 12Dec2020 11:30 at the age of 28 years old for COVID-19 immunization. The patient had not been tested for COVID-19 since the vaccination. On 11Jan2021 20:00, the patient experienced fatigue, body aches, sensitive skin, and chills. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.

On the day of the shot, hives?broke out in hives in the evening after a hot shower. Every day I have had itchy skin, almost like the feeling of dry skin, but with a red rash on face, chest, arms, and legs.

Started breaking out in hives; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received the first dose of BNT162B2, lot number: EL0142, via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma (had an Inhaler just for whenever it's bad but she hadn't taken it in probably over a year), had typhoid once in the past as a child and had an allergy to Sulfa drugs (Unspecified Medication). The patient's concomitant medications were not reported. Patient stated she got the Vaccine on 30Dec2020 and a week later that would have been on 06Jan2021, she believed that was the date that evening she started breaking out in hives and she typically had typhoid once in the past as a child because she had an allergy to Sulfa drugs (Unspecified Medication). So she got hives a week later and she got them again three days later both in the evening and both disappeared by the time. She woke up in the morning she didn't take any antihistamines or anything. The patient wanted to know if that was a reaction other people were having and could provide any advice on second dose. She was supposed to get the second dose on the 21Jan2021. Patient stated it was twice that she had received the vaccine, she broke out with hives and it was not typically normal for her. The patient had lab testing a couple of weeks prior to the report, just took a whole blood drawn to check some of her levels. No treatment was received for the event. The outcome of the event was recovered in Jan2021.

1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heightens, slight chills, more fatigue 7pm ear itch both sides, all ear involved even lobe and red 9pm soreness, chills, arm pain 1/15 Friday 7:30am nausea, dizziness, sinus pressure, headache, arm pain 1pm extreme fatigue, sleep for afternoon, arm pain 4pm headache intensify, arm pain 6pm both ear swelling, warmth, extreme itch 9pm lingering headache, arm pain improves 1/16 Saturday 7am ear itch and rash spread to back of neck 12pm telehealth - recommended benadryl, Rx prednisone Benadryl ineffective, rash remains 8pm- itch inside ears, red scaly ears, hot after washing, extremely scaly 1/17 Sunday 6 pills of methyl prednisone Hives moved to back of neck following the back of ear 1/18 Monday 6pills prednisone inside ear itch, ear lobes itch, skin very flaky 1/19 Tuesday Go to urgent care 6pills prednisone 1/21 Thursday Rash spreads to collarbone Go to TMC Dermatology prednisone continued 1/24 Sunday Stopped steroid under recommendation of MD Huge flare up around neck, chest, back and down to lower body Itch continues to night, lack of sleep 1/27 Wednesday Placed back on steroid (16 day course) Rash remains, itch subsided Decision to not take second dose

1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness

Sore injection site at 10:00pm day of injection. Morning of day after chills, fever, sore throat, cough, short of breath. 48 hours later same symptoms but fever is worse. I?ve been alternating Tylenol and Advil Q 4 hours. Had a COVID test performed on 1/26/2021. Negative results morning of 1/27/2021. Currently extremely sore throat, cough, fever, short of breath.

Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-Severe, Systemic: Other- Itching-Severe

1 hour after vaccine received, patient experienced itching, initially she felt it could have been related to something else, however after going home and showering, itching persisted and involved the entire body. Injection site developed bumps that looked like hives per report and spread the entire arm. The patient took a dose of diphenhdyramine however itching and hives continued into the night and could not sleep, another diphenhdyramine dose was taken and she was able to sleep for a few hours. She went to see her PCP who deemed this an allergic reaction to the vaccine, gave her oral steroid along w topical cream. The bumps and hives subsides within 24 hours of steroid use, and the itching resolved after 2 days of initiating steroid (3 days post vaccine) . Steroids were started 1 day post vaccine. PCP recommended patient sees an allergist for further investigation and refrain from second dose of vaccine

Delayed redness/warm to touch around injection site worsening on Day 8 post vaccine with itchiness. 2.25 inches by 2 inches in size

Sudden redness over chest, neck, and face. Heart rate at rest jumping from 73 to 165 bpm, sweating, dizziness, feeling on verge of passing our. Heart rate and symptoms subsided at 15 min. Dizziness continued for next hour with fluctuations in heart rate and Blood pressure taken at 110/88.

Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.

Hives developed on the injection arm and spread across her chest; intense heart palpitations; weakness/dizziness; weakness/dizziness; This is a spontaneous report from a contactable Nurse (patient). A 29-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 07Jan2021 13:00 at SINGLE DOSE for COVID 19 vaccination. The patient was not pregnant. Medical history included Shellfish allergy. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 on 17Dec2020 07:00 AM at left arm for COVID 19 vaccination. On 07Jan2021, hives developed on the injection arm and spread across her chest within 5 minutes of receiving the vaccine, along with intense heart palpitations and weakness/dizziness. Resolved spontaneously after 10 minutes without any use of epinephrine or other medications. Oral diphenhydramine was taken afterwards. Treatment drug oral diphenhydramine received for events. The outcome of the events was recovered in Jan2021. No covid prior vaccination, no covid test post vaccination. Information on the lot/batch number has been requested.

The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it was on fire. I had a rash on the opposite arm that i had the injection. I took benadryl to help with the rash in the morning and at night. That night i was freezing and i woke up in a sweat. This morning i woke up and the rash looks worse.

This is a spontaneous report from a non-contactable nurse. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), intramuscular the first dose on arm left on 23Dec2020 09:00 am, the second dose on right arm on 14Jan2021 09:00 am, both at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (MOTRIN [IBUPROFEN]). The patient experienced pain injection site, fever of 102.2, malaise, all on an unspecified date with outcome recovered. Therapeutic measures were taken as a result of pain at injection site. The patient underwent lab tests and procedures which included Covid test with nasal swab: negative on 16Jan2021. The patient is not pregnant. No follow-up attempts are possible. No further information is expected.

raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.

red circle around the injecting site; injecting site, itchy; injecting site; a hard ball underneath; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El3246 and expiry date unknown) via unspecified route of administration at the left arm on 13Jan2021 09:15 at single dose for Covid-19 immunization in a hospital. Medical history included liver tumors, and allergies to "sulfer", thyroid (disorder), anxiety and blood pressure (abnormal). Concomitant medications included thyroid, anxiety and blood pressure medications. The patient has no other vaccine in four weeks. On 14Jan2021, the patient experienced red circle around the injecting site, itchy and a hard ball underneath. The patient did not receive treatment due to the events. The outcome of the events red circle around the injecting site, itchy and a hard ball underneath was not recovered.

the redness around the site came back; the redness around the site came back; headache; body aches; chills; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3246 and Expiration Date unknown) via intramuscularly on 12Jan2021 08:15 AM (Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via intramuscularly on 21Dec2020 05:15 PM (Right arm) at single dose for COVID-19 immunisation. With first dose, patient had redness to the site the day after injection. It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine, the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large (have pictures for comparison throughout the days). Treatment included oral antibiotic and it slowly began to fade and go away. Other medical history was reported as Attention deficit hyperactivity disorder (ADD), eczema, psoriasis. The concomitant medications included unspecified Birth control, vitamin b complex (VITAMIN B) and ergocalciferol (VIT D). No other vaccine in four weeks. After second vaccine patient had a typical immune response- headache, body aches, chills, etc on the first day after vaccination and then on the second day post vaccination the redness around the site came back. Patient worried it was going to continue to grow again. The outcome of events was unknown.

Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain through the left arm and around the injection site.

Mild itching, fatigue, rash, muscle aches. Moderate headache. Patient described rash as red blotchy spots on forehead and sides of her temple. Ears also were hot to touch.

Red welt over injection site, slowly growing bigger every few hours. It?s hot, sore and itchy. Just started showing as of 1/29/2021...as of now it is the size of a kiwi. When vaccine was administered, doctor must of hit a blood vessel. I bled down my arm.

I got the 1st Pfizer vaccine on 1/6/21, I had mild itching and fleeting chills after the shot. I took some Benadryl when I got home, and I was ok. I got the 2nd vaccine on 1/27/20 at 8 am. At around 8:10 I started getting itchy. The itching escalated, and I notified one of the nurses at the vaccination clinic. At around 8:32 they administer Claritin and called the rapid response team because I started having tightness in my chest (similar to my asthma reaction). The Physician who responded to the rapid response recommended that I be transferred to the ER for observation. I was taken to the ER and was given IV fluids with Solu-Medrol, Pepcid, and Benadryl. I had some improvement, but still experienced some mild itching, which is still ongoing (as of today 1/31/21 @ 01:47). I?ve had a headache and fatigue the past 2 days, the headache has resolved, but still feeling fatigued. I was prescribed prednisone and I am to take Benadryl as needed. I have been compliant with all my prescribed meds. I had a follow up with my PCP on 1/28/21 @ 8:10, she recommended that I continue taking the medications prescribed in the ER, and to follow up with the office for further assistance or go back to the ER if I have tightness in my chest. She also recommended taking Tylenol for the headache. As of this morning (1/31/21 02:05), I have not had tightness in my chest. I've been using my prescribed Inhalers (both the flovent and albuterol).

Immunization Admin. COVID-19 30mcg/0.3mL Dosage 1st Dose Pfizer (Z23); ­COVID-19 Vaccine, 30 Mcg/0.3mL Dosage, Diluent Reconstituted, For Intramuscular (Z23) (IM injection) Manufacturer Pfizer Lot EL3249 Expiring 05/01/2021 ­ Vaccination received on 1-12-21, left deltoid. She had localized stinging in left proximal lateral arm for first 12-24 hrs; then itchy welt at injection site and nearby separate itchy small area on proximal lateral arm on 1-13-21. Progressive increase in size/persistent itching. Evaluated on 1-19-21. Afebrile. There is 2x2.5 cm mildly tender, slightly indurated nodularity surrounded by 10x9 cm confluent erythema demarcated by pen, which has extended to 12x9.5 cm in widest margins. Confluent erythema is slightly warm to touch, nontender, nonindurated, no red streaks. No left axillary adenopathy. Treated with antihistamines.

After 7 days, a full body rash developed along with petechia on bilateral calf and bilateral upper arm. Current treatment is antihistamines and pramoxine lotion

I have been extremely itchy all day. It hasn?t been around the injection site. I had hives for about an hour then they went away but the itching stayed. I had it on my head, stomach, chest, wrists, neck, feet and back. I spoke with a pharmacist and took Benadryl and it helped.

the redness came back but it was itchy, hot to touch, and hard; the redness came back but it was itchy, hot to touch, and hard; With my first vaccine I had redness to the site the day after injection; It was probably about a quarter to half dollar in size and was red and inflamed; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 21Dec2020 17:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADD), eczema, and psoriasis; all from an unknown date. Patient was not pregnant. Concomitant medications included vitamin b complex, ergocalciferol (VIT D), and birth control. It was reported that with patient's first vaccine, the patient had redness to the site the day after injection (22Dec2020). It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine (reported as '27Dec2020 19:00'), the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large. The patient visited a physician, and was placed on an oral antibiotic and it slowly began to fade and go away. The outcome of the events was recovered.

Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.

Eight days after I received the first dose I experienced redness and swelling around the injection site. It continued to get larger over the next two days, measuring 4 inches in diameter. It was associated with mild pruritis. There was diffuse swelling of the area but no discrete fluid collection. I couldn't lift my left arm above shoulder height by the end of the second day. After discussion with our infectious disease doctor and an internist we decided that since the area had continued to get larger that I should have a steroid injection. I received 40mg IM solumedrol two days after it appeared and it markedly improved 6 hours later with resolution of symptoms about 24 hours later.

Site: Pain at Injection Site-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Other- Light-headed, numbness ONLY in lower hand and wrist-Medium

hives/hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest; soreness (a little bit); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Unknown lot number and expiration), intramuscular in left upper arm on 31Dec2020 at a single dose for COVID-19 prophylaxis. Medical history included cat allergy/seasonal and animal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for cat allergy. The patient previously received flu shot for immunization on unspecified date. The patient reported that she received the first dose of vaccine on 31Dec2020 and experienced soreness (a little bit) but was no difference from the flu shot. Last night (18Jan2021), hives started to appear. She took a Zyrtec this morning (19Jan2021) that she usually takes at night to alleviate the symptoms. She takes Zyrtec because she has a cat allergy and also reported to have changed her laundry detergent. The patient was wondering if there have been any reports of delayed allergic reactions to the COVID-19 vaccine. She said that she just got hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest last night. She may have some on her back, but she has not looked yet. She has had this type of reaction before with an antibiotic in the past. She is supposed to get the second dose on Thursday 21Jan2021. She noticed the hives last night and they seem to have gotten a little bit worse overnight but are about the same since she has gotten up. She said that she has allergies, but they are seasonal and animal allergies. She has also been using the same body wash and laundry detergent and stated that nothing has really changed with her. She also said that her partner that lives with her has not had any skin issues. The patient had not yet recovered from the event hives, while unknown outcome for the remaining event. Information on the lot/batch number has been requested.

Began experiencing full body itchiness about 1.5 weeks after receiving her first COVID vaccine dose. She takes benadryl at night to help with the symptoms. When the benadryl wears off the symptoms return. Still experiencing itchiness.

Received Pfizer first dose at 7:52am. While in Observation area of Vaccination Clinic (with a recommended 30 min observation time), within 15 min patient complained of "Itchy arms". I noticed red, blotchy rash on her chest. She stated her breathing was fine/no issues with breathing. Elevated her feet. BP= 123/85, O2Sats= 98%. Patient said she had pre-medicated with Benadryl and had an Albuterol inhaler and Epi Pen she had brought with her to her Vaccination appointment. She then started clearing her throat. Epi pen recommended for her to take-> she declined, stating her breathing was fine, and its too painful to take and bruises her skin and wasn't having trouble breathing. Patient brought to Emergency room within hospital.

Patient received Pfizer first dose at 7:52am. Came to Observation area with a recommended 30 min observation time. Within 15 min in OBS area patient complained of ""Itchy arms"". I noticed red, blotchy rash on her chest. She stated her breathing was fine/no issues with breathing. Elevated her feet. BP= 123/85, O2Sats= 98%. Patient had pre-medicated with Benadryl and had an Albuterol inhaler and Epi Pen she had brought with her to her Vaccination appointment. She then started clearing her throat. Epi pen recommended for her to take-> she refused, stating her breathing was fine, and its too painful to take and bruises her skin and wasn't having trouble breathing. Rapid Response called. Again Epi pen recommended- patient declined. She was brought to Emergency room and report given.

rash and hives all over body; rash and hives all over body; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EJ1685; expiry date: not known), intramuscular in the left arm on 17Jan2021 08:30 at single dose for COVID-19 immunization. There was no medical history. The patient is not pregnant. No known allergies. Concomitant medication included unspecified medication (other medication given in two weeks). No other vaccine in four weeks. No COVID prior to vaccination and not tested with COVID post vaccination. The patient experienced rash and hives all over body on 18Jan2021 11:00. These resulted in physician's clinic visit. Therapeutic measures were taken as a result of rash and hives all over body with prednisone, Benadryl, and Kenalog. The outcome of the events was recovered in Jan2021.

Broke out into a full body itchy rash several hours after receiving vaccine. Went to emergency room for visual examination. Was determined to be a mild allergic reaction, and benadryl was administered. Was evaluated at primary care doctor after rash did not go away after 2 days. No additional treatment was administered. Rash went away after 4 days. Also, 12 hours after receiving the vaccine I had severe fatigue, chills, nausea/vomiting, and headache. Was treated at home with advil and promethazine. These symptoms went away around 36 hours after vaccine was administered.

RIGHT ARM VERY SORE; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on Right arm from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE (first dose) for covid-19 immunisation. Medical history included PCOS, hypothyroidism, hyperparathyroidism, hypertension. The patient has allergies with amoxicillin and oxybenzone. The patient experienced right arm very sore on 05Jan2021 with outcome of recovered. The patient is not pregnant at the time of vaccination. No treatment was received for the event. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

erythematic rash to torso, itching, T 103, body aches. Saught tx with urgent care, tx oral steroids. Then resolved after 2 days sterids tx felt much better.

Mild hives on left forearm day 1, took loratidine. Moderate hives on both forearms after 7 days. Continue to have itchy legs and hives in forearms.

Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous report from a (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration in left arm on 14Jan2021 11:45 at first single dose for COVID-19 immunization. Medical history included covid-19 (covid prior vaccination), known allergies: Penicillin, sulfa drugs. There were no concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced body aches, joint pain and chills began about 16 hours after receiving vaccine (15Jan2021). Mouth swelling and hives in mouth and lips began 4 days after (18Jan2021 10:00 AM). AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment included: prescribed steroids. Covid was not tested post vaccination. Outcome of the events was recovering. No follow up attempts are possible. No further information is expected.

Sore throat; headache; severe pain at injection site; body aches; congestion/runny nose; congestion/runny nose; fever; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient receive the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the hospital, via an unspecified route of administration on 19Jan2021 at 15:15 on the left arm at a single dose for COVID-19 immunization. Medical history included migraine with aura from an unknown date and unknown if ongoing. Concomitant medication included unspecified prenatal vitamins. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sore throat, headache, severe pain at injection site, body aches, congestion/runny nose and fever all on 19Jan2021 at 17:30. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious. The patient underwent a post vaccination COVID test via nasal swab on 21Jan2021 with a negative result.

Approximately an hour after vaccine administration I developed a scratchy throat. Soon after I felt like my eyes were swollen, though not swollen visibly. I also had mild itching across my arms. These symptoms improved within 3-4 hours without medical intervention.

On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 patient reported beginning 2/5/21 early evening she began having overall body rash and body ache that progressed over the next few days to sore/swollen throat, voice loss, nausea, intermittent fever, loss of taste and smell, headache, and diarrhea. Tested COVID-19 negative 2/9/21, still having symptoms. Stated has not seen her healthcare provider but will contact for care.

fatigue, fever, chills, aches, sweats, injection site soreness. Onset 8-10 hours post-vaccine, lasted 48 hours to varying degrees of severity.

trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Rash on neck; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 21Jan2021 at a single dose on right arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 29Dec2020 for COVID-19 immunization (brand: Pfizer, lot number: EL1284, administration time: 02:45 PM, route: intramuscular, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on neck on 23Jan2021 09:00. The event was reported as non-serious. The patient has not been tested for COVID since the vaccination. No treatment was received for the adverse event. The patient has not recovered from the event.

Rash on right side of neck; Rash of bumps on the left arm where injection happened; Rash of bumps on the left arm where injection happened; Some difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 22Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies and migraine. Concomitant medication included ibuprofen, albuterol [salbutamol] and sumatriptan. The patient previously took clindamycin and experienced drug allergy. The patient experienced rash of bumps on the left arm where injection happened, rash on right side of neck some difficulty breathing on 22Jan2021 19:30. The patient received treatment Benadryl and albuterol to treat symptoms. The outcome of events was recovered in Jan2021. Information on the Lot/Batch number has been requested.

After second shot had numbness on the left side of face approximately ten minutes after shot, was less numbness than shot one. Approximately 3 hours after shot developed hives on same area of face that was number. Hives last about 2 hours and cleared up with OTC Benadryl. Face numbness stopped about 6.5 hours after injection

anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.

Hives 4 days after first dose that was self-limiting and resolved with Benadryl, reported at time of 2nd dose

Left second toe became discolored and stinging/painful, then left 4th toe. Exam c/w pernio/chillblains

Swelling,heat, and redness at injection site. Severe headache, fever of at least 101.5, chills, aches, lethargy, inappetence.

the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was freezing at night and i woke up in a sweat; I was freezing at night and i woke up in a sweat; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old. Lot number was EL9262. Medical history was none. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old (lot number was EL3248). Concomitant medications included desogestrel, ethinylestradiol (ISIBLOOM) for birth control, ESCITALOPRAM OXALATE (LEXAPRO), vitamin D. On 28Jan2021 at 07:45, the patient woke up and the arm where she received the injection felt like it was on fire; the opposite arm had a rash on it; the patient took benadryl that morning and at night after she got home from work. On 28Jan2021, the patient was freezing at night and he woke up in a sweat. On 29Jan2021, the rash looks worse. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.

PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 hours following first dose on 1/20/21. After second dose of vaccine, reported: itching, stridor, cough, nausea, vomiting, dizziness, tachycardia, acute change in mental status, temp102.5, DBP >100, tremors for 48 hours. Did not see doctor or other healthcare provider.

Between the first and second dose (1/11/21), I had significant bruising on my body. I was also light headed from time to time with decreased appetite, anxiety and heart burn. I went in for blood work and my platelet count had dropped to 5 and I was asked to come into the ER for platelet transfusion. I also received IVIG (x1) + steroid treatment (x2) and took oral steroids 4 days after.

This is a spontaneous report from a contactable other health care professional (patient self-reported). A 29-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3247 and expiry date was not provided), via an unspecified route of administration, at arm Right on 26Jan2021, at a single dose for COVID-19 immunization, in Workplace clinic. Patient's medical history was reported as none and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not received any other vaccines within 2 weeks of vaccination of COVID vaccine. On same day (26Jan2021), the patient experienced soreness in right arm and it is persistent after 24hours. Patient was not received any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Seriousness of the event was reported as non serious. Outcome of the event was recovering.

2/18/2021 4:30am woke up nauseous, having muscle aches from injection site in left bicep to top of head on same side, not able to think clearly ?foggy?. 1:30pm having muscle aches in both sides of neck and headache left sided

High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.

She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nausea, vomiting, fatigue, myalgias, rash, which have persisted for 6 days.

Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to walk on feet and use hands.

Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. After about 20 minutes the numb like feeling had begun to regress back toward the injection site. It had not fully faded away after 30 minutes but did seem to be improving.

Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared. Monday redness on face and by Tuesday all hives had resolved. Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.

Fever, swollen lymph nodes, itchy skin, intense body acne (increased swelling and discharge from existing infections), muscle aches, body pain, prolonged fatigue, brain fog, persistent migraines, sweating, chills. All persisted for about a week.

Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Muscle pain across shoulders starting at 2pm after 9 am shot on 2/23. COVID arm, large red bump on arm, warm to touch and hot following morning, noticed at 7 am on 2/24. Under arm, armpit and down into rib area sore when arm is raised, noticed 7 am 2/24 pain gets worse throughout day. Pain in upper back across shoulders as well during day. All listed above is still ongoing at the same pain level.

Patient felt nervous, difficulty breathing and complained about swelling in the back of the throat within 15 minutes of administration. Her face was red and heart rate was elevated to 120bpm with blood pressure of 140/90mmhg.

Rash starting in center of chest and under breasts, spread to stomach, and spanned across sides of torso onto back. Spread mildly onto shoulder/neck. Pain/soreness at injection site, started a few hours after injection, and subsided a few days after injection.

Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurse reporting for herself. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old via intramuscular in the left arm on 28Jan2021 01:00 PM at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced rigors, pain at injection site, body aches on 29Jan2021 at 03:00 AM. No treatment was received for the events. The nurse considered the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

Currently pregnant (25 weeks) due June 9, 2021 - no known adverse events in the pregnancy. Injection site soreness, Vasomotor symptoms, nausea. Injection site soreness lasted 48 hours. Other symptoms lasted approximately 45 minutes.

My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out in a rash and became super itchy; Have hives; This is a spontaneous report from a consumer reporting for herself. A 29-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # em9809) vaccine , via an unspecified route of administration in the left arm on 24Feb2021 14:30 at single dose for covid-19 immunisation . Medical history included asthma , attention deficit hyperactivity disorder , polycystic ovaries , sleep apnoea syndrome, arthralgia , the patient was allergic to Albuterol, Penicillin, Cephalosporin, Iodine, Bees, all types of fish, all types of shellfish, peanuts, all types of tree nuts. Concomitant medication included cefixime (FLEXERIL), acetylcarnitine hydrochloride (NEUROTIN ), naproxen (MOTRIN). The patient experienced my mouth and tongue started itching on 24Feb2021 14:30 with outcome of not recovered , skin broke out in a rash and became super itchy on 24Feb2021 14:30 with outcome of not recovered , have hives on 24Feb2021 14:30 with outcome of not recovered. The reported events were considered Life Threatening. The patient received Benadryl, and got epi on hand as treatment. Follow up information has been requested.

Immunization administered on 12/27/2020. On 01/04/2021 I began to break out in full body urticaria with facial edema and joint pain. Followed up with allergist and rheumatology. Both ruled out allergy or rheumatological causes. Elevated CRP of 116. Ongoing urticaria outbreak since onset.

Injection site pain, tiredness after 30 minutes, muscle pain in right arm, - joint pain, injection site swelling, nausea, and headache.

Patient with prior hx of anaphylaxis - required 30 min wait, ~ 25 mins into wait time - reporting slight swelling of lips, sensation of itchy throat/tightening, appearance of hives on arms. Patient alert and oriented, breathing comfortably. Advised will take to ED dept for further evaluation - patient refusing wheelchair - ambulatory. Walked to ED dept with NP, report given to ED, registration completed.

Patient presented for her first covid vaccine today. She received the immunization in her right deltoid at 1703, was seated in the 15 minute observation area. After about 10 minutes, she reported feeling dizzy. RN alerted EMS who brought her for closer evaluation. While in EMS care, patient developed rash and hives on her neck and arms, swelling in her lips and tongue, shortness of breath with oxygen saturations in the 80's. EMS started a 20g Left antecubital IV, administered 50 mg benadryl IM, 125 mg solumedrol IV, placed patient on supplemental oxygen at 2L nasal canula. After medication administration, patient's rash and hives began to resolve and she was able to speak clearly after medication. Patient was transported to hospital via ambulance for further evaluation. VAERS documented.

After 30 minute observation period, pt. remoed her bandaid and stated she had a slight itching at the injection site. Slight redness noted, but pt. had been scratching. No swelling. Denied any other symptoms and states has had allergic reactions before and this didn't feel like one. Pt. was instructed to go to the ED if she had any worsening or concerning symptoms. Pt. verbalized understanding.

I started to have heart palpitations with a high heart rate. I called in to my telehealth and was told that it was vaccine related. It subsided after 36 hours. After the second dose I had flu like symptoms and brain fog for a day. I had bruising and a knot at the injection site that lasted for three weeks.

2 hours after the injection, patient developed hives on arms/legs. She took a benadryl and symptoms resolved. She had no previous allergic reactions.

Pfizer-BioNTech COVID-19 Vaccine EUA. Severe and unusual skin itchiness, scratching resulted in immediate bruising, patchy red skin, itchy throat and ears, fatigue, soreness, achiness Took benadryl and napped. Later took tylenol and ibuprofen

Raised rash that itches on skin only on areas where there are tattoos. Raised largest rash that itches stops at tattoo boarders. Swelling has caused the tattoos to swell up. Smaller rash bumps can be seen on top of tattoos that look different from the large welts. Primarily only on tattoos. OTC Topical cortisone cream has not relieved itching or welts. Prescription Topical Triamcinolone Acetonide Cream 0.1% has not made any changes.

sore neck; fatigue; Sore arm muscle at injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in arm left, on 18Feb2021 15:00, as single dose for COVID-19 immunization, at workplace clinic. Patient's medical history included Asthma, Herpes, Bipolar 2 Disorder. Patient had no Allergies to medications, food, or other products. Concomitant medications included valacyclovir, montelukast and lamotrigine (within two weeks of vaccination). Historical vaccine included first dose of BNT162B2 (lot number; unknown), via an unspecified route of administration, in Left arm, on 28Jan2021 3:00 PM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 15:00, the patient experienced sore arm muscle at injection site after injection and continuing into second day (19Feb2021); sore neck and fatigue starting the next morning. Patient was not received treatment for adverse events. Seriousness of the events was reported as non-serious. Outcome of the events was recovering. Information on the lot/batch number has been requested.

Approximately 3 to 4 minutes after receiving vaccine, patient stated she was not feeling good and patient turned red and fainted. She was sitting in chair so mom stood behind her with an ice pack behind neck and holding patient head while dad stood in front of patient. Her body became limp and mom was shaking her body on right side in attempt to wake patient up. Her eyes opened but was still unresponsive and she was breathing heavily for 30-40 seconds. After placing patient on floor and elevating her legs, patient stated she felt better but still fills nauseated. Paramedics were called.

Patient was brought to me by nurse who was with patient in waiting area when she became anxious after receiving Phizer COVID 19 vaccine. She was alert and oriented when I placed her in the sitting position on an exam table in the observation area. approximately 20 minutes later, she reported feeling itchiness in nose and lips. There was no swelling, redness noted. There was no rash, SOB, difficulty swallowing. She has taken Benadryl for similar symptoms in the past and requested she be given some. She was given Benadryl 50mg PO. VSS through out. Symptoms resolved over next 20 minutes. She was asymptomatic at 1210 and was discharged with sister to drive home.

The muscle around the injection site was very stiff shortly after the injection. No pain to touch around injection site. On 3/6/21 I started experiencing slight pain in my axillary region. Pain was probably 3 of 10. Stayed at this pain level until 3/8, when it started to increase and to date pain is increasing and there is a large lump in my under my arm. Lifting my arm above my shoulder increases pain. Pain also wraps around to my shoulder area. I have never had any pain in or around this region until after the vaccine.

The night of vaccination I felt awful like I had the flu and got hives up and down my legs. Since then I have felt malaise and general soreness as well as intermittent headaches etc. none of this is uncommon in my body (as I have autoimmune issues). But I am concerned it?s triggered an autoimmune flare. I no longer have hives (so I will check recovered) but still feel unwell.

soreness at the injection site (persisted 48 hours after injection), tired (persisted for 24 hours after injection), headache (began approximately 14 hours after injection and persisted for 12 hours), body aches (began 14 hours after injection and persisted for 12 hours), fever (began 14 hours after injection and persisted for approximately 12 hours), chills (began 14 hours after injection and lasted for approximately 6 hours), nausea (began 16 hours after injection and lasted for approximately 12 hours) No treatments were done. No medications were taken at the direction of the vaccine provider who directed that Tylenol should only be taken with a high grade fever in order to promote a full immune response. Mild dehydration 36 hours following injection likely due to nausea decreasing intake of food and liquids.

13 weeks pregnant, healthy. Rash start evening of vaccine, progressively worsened over the weekend, went to a dermatologist 4 days after vaccine with severe and widespread blisters on chest and back, diagnosed as shingles.

Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.

Developed a small light rash on Chest, near elbow and forearm, and above belly button. I have NOT gone to the doctor the get it checked. I have NOT develop any breathing issues just the light rash.

Onset within minutes: dizziness, confusion, and facial numbness in both cheeks, eyes, nose, jaw and muscle stiffness in the face which lasted until the following day. Following morning, there was sharp pain at the injection site and I was unable to lift my arm at all. In the evening I can lift it half way. Still experiencing 32 hours later: headache and brain fog and dissociated feeling, fatigue, and body aches. Neck remains stiff. Never had any adverse or allergic reaction to anything before and didn't become fully aware that something wasn't right until after I left the facility yesterday.

Patient pre-medicated for vaccine with 25mg Benadryl Immediately developed itchy hives. Went to the ER, was given Benadryl, Pepcid, and Decadron Symptoms resolved To follow up with PCP as needed, take Benadryl/Pepcid as needed

Pt received her first dose of Pfizer LOT#: ER2613. Pt contacted EMT and reported that she had heart palpitations which lasted about three minutes. Pt also had shoulder pain on left side where she was vaccinated. EMT took vital signs. BP: 118/80, Pulse: 82, 02: 100%. Pt stated that she has had a history of anxiety and high cholesterol. Pt stayed an extra 15 minutes. Pt reassessed, pt stated that she was feeling better. Pt reported that she had not eaten breakfast and requested to have some water. Pt left with husband with a steady gait at 1425.

on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.

My face and neck turned bright red and became very hot. I have pictures for the progress of the redness if needed too.

On Tuesday the injection site developed hives. On Wednesday I felt very sick. On Saturday I lost all sense of taste and smell.

PATIENT STARTED TO EXPERIENCE WARMTH AT THE SITE, TINGLING ALONG THE INJECTED ARM, AND DIZZINESS. STAFF NURSES APPLIED COLD PACK TO INJECTION SITE, TOOK VITALS, GAVE PATIENT WATER, MONITORED FOR WORSENING SYMPTOMS. KEPT PATIENT AT SITE FOR OBSERVATION FOR 30 MINUTES.

Patient received vaccine and was waiting for 30 minutes in the observation area due to history of allergic reactions. At 20-minutes post-vaccination, patient experienced hives and swelling in her tongue. Patient reported to EMS that it felt like previous allergic reactions. EMS assessed VS. BP 151/101, HR 98, O2 sat 97%. EMS administered 1 Epi pen into the R thigh. Patient had a rapid resolution of symptoms. EMS recommended transport to ER, patient agreed. Transported to EMS. Post epi vitals were 150/69, HR 80, O2 Sat 97%.

Redness and swelling below injection site; Redness and swelling below injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN9581) via an unspecified route of administration in left arm on 07Feb2021 15:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not receive other vaccine in four weeks prior to vaccination and other medications in two weeks. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3246) in the left arm on 17Jan2021 15:00 for COVID-19 immunisation and amoxicillin and had known allergies. On 08Feb2021 08:00, the patient developed redness and swelling below injection site similar to the "covid arm" from the Moderna vaccine. No treatment was received for the adverse events. The patient did not test COVID post vaccination. The outcome of the events was recovering.

Very minor reaction localized to the injection site; the area is hot, swollen, with a few hives; the area is hot, swollen, with a few hives; the area is hot, swollen, with a few hives; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 13Feb2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. There was no medical history. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included sertraline and bupropion hydrochloride (WELLBUTRIN), both from unknown dates and unknown if ongoing for unknown indications. The patient also received unspecified combination birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced very minor reaction localized to the injection site and the area was hot, swollen, with a few hives on 20Feb2021 at 14:00. Symptoms only appeared 7 days after injection. The patient did not receive any treatment for the events. The clinical outcomes of very minor reaction localized to the injection site and the area was hot, swollen, with a few hives were recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.

Sunday 3/21 (2 days after vaccine): itchy rash on entire neck, shoulder, ears and left abdomen - took Claritin and used hydro cortisol cream and the rash subsided. Monday 3/22: mid way through work shift, felt extremely dizzy, jittery and light headed. Difficult to stand and walk on my own and rash started to come back. Went to care.

About an hour after shot in my left arm, I began to experience itchy skin, red bumps on inner elbow on left arm. Now the bumps are discolored and brown/black and I have dark blotch on my inner elbow and the skin is textured

High fever, aches, chills, nausea, soreness at injection site, trouble sleeping, headaches, joint pain

I received the shot at 8:30 AM. No reaction until around 12:30PM when I noticed mild soreness in my arm muscle where I received the shot. Then around 5:30PM I became progressively fatigued and very mildly feverish.

Red blotchy patch of skin around injection site, first noticed on 3/20/21 and is still present as of today 3/24/21.

Patient reported severe rash on right arm and spread all over neck. No reports of trouble breathing or hives, just itchiness. Recommended to take an antihistamine and continue to monitor. If any signs of difficulty breathing occur to call 911, if it does not improve over the next 2 days to contact their primary doctor.

sore injection site, body aches, low grade fever, general fatigue, swollen lymph nodes (neck), headache at base of skull, swollen and painful left nostril. Patient took 500mg of acetaminophen at 5pm and 9pm and again at 8am the following day. By 11am the next morning, all symptoms except the swollen and painful left nostril and sore injection site resolved. Swelling and pain lessened gradually around 11am and were fully resolved within 72 hours of the injection.

Almost immediately after receiving the vaccine I started feeling numbness in my left arm (injection site), dizzy, nauseous, and experienced tunnel vision. I also started profusely sweating (forehead). I reported my symptoms to the nurse who took my temperature, BP, and heartrate. I had a low grade fever (99 degrees) and slightly elevated BP. I drank water and remained at the site for another 30 minutes and my vitals were checked again before I left.

Patient collapsed onto floor 10min s/p Pfizer vaccination patient stated feeling dizzy and not realizing she fell. Patient has history of fainting after shots but did not advice anyone. Patient got quarter of an in laceration on forehead. Vital signs stable, cleaned and wrapped laceration and sent with paramedics to ER.

Patient reported itchiness on her neck, leg . Pt has a history of anaphylaxis. MD administered Zyrtec PO

The day of the vaccine I had horrible body aches and horrible nausea as well that lasted approximately 36 hours. But starting on the 24th so about 11 days post vaccine, my injection site got very red and itchy. The redness then spread down my arm and I developed hives around my elbow. I treated it with a topical Benadryl spray to get rid of the itchiness, and the hives lasted about 36 hours and have already almost faded.